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Amino acids

Important building blocks

Amino acids are part of most metabolic processes of the human body. Therefore they are also essential components of numerous pharmaceutical and dietary products and clinical nutrition and contribute to restoring and preserving human health.

AMINO has been working for the efficiency and purity of these pharmaceutical substances. At our factory in Frellstedt, Germany we produce amino acids and other biological substances for customers all over the world.

Read more about the high quality standards, modern technology and AMINO’s attractive spectrum of products.

Overview

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Amino acids
  • DL-Aspartic acid
    • EP 9 infusion grade
    • EP 9 oral grade
  • DL-Serine
    • EP 9 oral grade
    • USP 39 oral grade
  • Glycine
    • EP 9 infusion grade
    • EP 9 oral grade
    • EP 9 / USP 39 oral grade
    • USP 39 oral grade
  • L-Alanine
    • EP 9 infusion grade
    • EP 9 oral grade
    • EP 9 / USP 39 oral grade
    • USP 39 oral grade
  • L-Asparagine Anhydrous
    • EP 9 infusion grade
    • EP 9 oral grade
  • L-Asparagine Monohydrate
    • EP 9 infusion grade
    • EP 9 oral grade
    • EP 9 / NF 34 oral grade
    • NF 34 oral grade
  • L-Aspartic acid
    • EP 9 infusion grade
    • EP 9 oral grade
    • EP 9 / USP 38 oral grade
    • USP 38 oral grade
  • L-Cystine
    • EP 8 infusion grade
    • EP 8 oral grade
  • L-Glutamic acid
    • EP 9 infusion grade
    • EP 9 oral grade
  • L-Glutamine
    • USP 39 oral grade
  • L-Histidine
    • EP 9 infusion grade
    • EP 9 oral grade
  • L-Isoleucine
    • EP 9 infusion grade
    • EP 9 oral grade
    • EP 9 / USP 39 oral grade
    • USP 39 oral grade
  • L-Leucine
    • EP 9 infusion grade
    • EP 9 oral grade
    • EP 9 / USP 39 oral grade
    • USP 39 oral grade
  • L-Methionine
    • EP 9 infusion grade
    • EP 9 oral grade
    • EP 9 / USP 39 oral grade
    • USP 39 oral grade
  • L-Phenylalanine
    • EP 9 infusion grade
    • EP 9 oral grade
    • EP 9 / USP 39 oral grade
    • USP 39 oral grade
  • L-Serine
    • EP 9 infusion grade
    • EP 9 oral grade
    • EP 9 / USP 39 oral grade
    • USP 39 oral grade
  • L-Threonine
    • EP 9 infusion grade
    • EP 9 oral grade
    • EP 9 / USP 39 oral grade
    • USP 39 oral grade
  • L-Tryptophan
    • EP 9 infusion grade
    • EP 9 oral grade
    • EP 9 / USP 39 oral grade
    • USP 39 oral grade
  • L-Tyrosine
    • EP 9 infusion grade
    • EP 9 oral grade
    • EP 9 / USP 39 oral grade
    • USP 39 oral grade
  • L-Valine
    • EP 9 infusion grade
    • EP 9 oral grade
    • EP 9 / USP 38 oral grade
    • USP 38 oral grade
  • N-Acetyl-L-Methionine
    • Oral grade
  • N-Acetyl-L-Tyrosine
    • EP 9 infusion grade
    • EP 9 oral grade
Betaine (Trimethylglycine)
  • Betaine Anhydrous
    • Pharmaceutical oral grade
More active pharmaceutical ingredients (APIs)
  • L-Malic acid
    • EP 9 infusion grade
    • EP 9 oral grade
Amino acids
DL-Serine
General
DL-Serine
Stability

Product is stable for 4 years from date of production if stored under recommended conditions in original packaging.

Storage

Dry and dark at room temperature in tightly closed container

Chemical data
Formula
C3H7NO3
CAS Number
302-84-1
Packaging
25 kg Unit
Outer container
Fiber drum
Outer liner
Alu/PE comp.
Inner liner
LDPE
USP 39 oral grade
(DL-Serine)
Parameter
Limit
Appearance:
White or almost white crystalline powder or colourless crystals
passes
Identity
passes
Specific optical rotation (on dry basis) (10.0 % (m/V) in 2 M HCI at 20 °C [α]D20)
–0.5° to +0.5°
Ninhydrin-positive substances (TLC)
passes
Chlorides
≤ 500 ppm
Sulphates
≤ 300 ppm
Iron
≤ 30 ppm
Heavy metals (as Pb)
≤ 15 ppm
Loss on drying
≤ 0.2 %
Residue on ignition
≤ 0.1 %
Assay (on dry basis)
98.5 to 101.5 %
Organic volatile impurities
passes
Total viable aerobic count
≤ 100 CFU/g
Moulds and yeasts
≤ 10 CFU/g
Salmonella
In 1 g n.d.
Escherichia coli
In 1 g n.d.
General
DL-Serine
Stability

Product is stable for 4 years from date of production if stored under recommended conditions in original packaging.

Storage

Dry and dark at room temperature in tightly closed container

Chemical data
Formula
C3H7NO3
CAS Number
302-84-1
Packaging
25 kg Unit
Outer container
Fiber drum
Outer liner
Alu/PE comp.
Inner liner
LDPE
EP 9 oral grade
(DL-Serine)
Parameter
Limit
Appearance:
White or almost white crystalline powder or colourless crystals
passes
Identity (A. Specific optical rotation/ B. IR)
passes
Test on turbidity
(5.0 % (m/V) in H2O)
≤ Ref. Susp. I
Test on colour
(5.0 % (m/V) in H2O)
≤ BY6
Specific optical rotation (on dry basis)
(10.0 % (m/V) in 2 M HCI at 20 °C [α]D20)
–0.5° to +0.5°
Ninhydrin-positive substances (HPLC)
▪ Each impurity
▪ Sum of impurities
 
≤ 0.2 %
≤ 0.5 %
Ammonium
≤ 0.02 %
Chlorides
≤ 200 ppm
Sulphates
≤ 300 ppm
Iron
≤ 10 ppm
Loss on drying
≤ 0.5 %
Residue on ignition
≤ 0.1 %
Assay (on dry basis)
98.5 to 101.0 %
Total viable aerobic count
≤ 1000 CFU/g
Moulds and yeasts
≤ 100 CFU/g
Salmonella
In 1 g n.d.
Escherichia coli
In 1 g n.d.
Glycine
General
Glycine
Stability

Product is stable for 4 years from date of production if stored under recommended conditions in original packaging.

Storage

Dry and dark at room temperature in tightly closed container

Chemical data
Formula
C2H5NO2
CAS Number
56-40-6
Packaging
25 kg Unit
Outer container
Fiber drum
Outer liner
LDPE
Inner liner
LDPE
EP 9 infusion grade
(Glycine)
Parameter
Limit
Appearance:
White or almost white crystalline powder
passes
Identity (A, IR)
passes
Test on turbidity
(10.0 % (m/V) in H2O)
≤ Ref. Susp. I
Test on colour
(10.0 % (m/V) in H2O)
≤ Y7
pH
(5.0 % (m/V) in H2O)
+5.9° to +6.4°
Related substances (HPLC)
• Glycine Anhydride
• Diglycine
• Triglycine
• each other impurity
• total of impurities
 
≤ 0.10 %
≤ 0.10 %
≤ 0.10 %
≤ 0.10 %
≤ 0.2 %
Other amino acids (AAA)
• individual impurity
• total of impurities
• Ammonium
 
≤ 0.10 %
≤ 1.0 %
≤ 0.02 %
Chlorides
≤ 75 ppm
Heavy metals (as Pb)
≤ 10 ppm
Loss on drying
≤ 0.5 %
Residue on ignition
≤ 0.1 %
Assay (on dry basis)
98.5 to 101.0 %
Total viable aerobic count
≤ 100 CFU/g
Moulds and yeasts
≤ 10 CFU/g
Salmonella
In 1 g n.d.
Escherichia coli
In 1 g n.d.
Pseudomonas aeruginosa
In 1 g n.d.
Staphylococcus aureus
In 1 g n.d.
Endotoxins
< 6 EU/g
General
Glycine
Stability

Product is stable for 4 years from date of production if stored under recommended conditions in original packaging.

Storage

Dry and dark at room temperature in tightly closed container

Chemical data
Formula
C2H5NO2
CAS Number
56-40-6
Packaging
25 kg Unit
Outer container
Fiber drum
Outer liner
LDPE
Inner liner
LDPE
USP 39 oral grade
(Glycine)
Parameter
Limit
Appearance:
White or almost white crystalline powder
passes
Identity
passes
Chlorides
≤ 70 ppm
Sulfate
≤ 65 ppm
Hydrolyzable substances
passes
Loss on drying
≤ 0.2 %
Residue on ignition
≤ 0.1 %
Assay (on dry basis)
98.5 to 101.5 %
Total viable aerobic count
< 100 CFU/g
Moulds and yeasts
< 10 CFU/g
Salmonella
In 10 g n.d.
Escherichia coli
In 10 g n.d.
Pseudomonas aeruginosa
In 10 g n.d.
Staphylococcus aureus
In 10 g n.d.
General
Glycine
Stability

Product is stable for 4 years from date of production if stored under recommended conditions in original packaging.

Storage

Dry and dark at room temperature in tightly closed container

Chemical data
Formula
C2H5NO2
CAS Number
56-40-6
Packaging
25 kg Unit
Outer container
Fiber drum
Outer liner
LDPE
Inner liner
LDPE
EP 9 oral grade
(Glycine)
Parameter
Limit
Appearance:
White or almost white crystalline powder
passes
Identity (A. IR)
passes
Test on turbidity
(10.0 % (m/V) in H2O)
≤ Ref. Susp. I
Test on colour
(10.0 % (m/V) in H2O)
≤ Y7
pH
(5.0 % (m/V) in H2O)
+5.9° to +6.4°
Related substances (HPLC)
• Glycine Anhydride
• Diglycine
• Triglycine
• each other impurity
• total of impurities
 
≤ 0.10 %
≤ 0.10 %
≤ 0.10 %
≤ 0.10 %
≤ 0.2 %
Other amino acids (AAA)
• individual impurity
• total of impurities
• Ammonium
 
≤ 0.10 %
≤ 1.0 %
≤ 0.02 %
Chlorides
≤ 75 ppm
Heavy metals (as Pb)
≤ 10 ppm
Loss on drying
≤ 0.5 %
Residue on ignition
≤ 0.1 %
Assay (on dry basis)
98.5 to 101.0 %
Total viable aerobic count
≤ 1000 CFU/g
Moulds and yeasts
≤ 100 CFU/g
Salmonella
In 1 g n.d.
Escherichia coli
In 1 g n.d.
Pseudomonas aeruginosa
In 1 g n.d.
Staphylococcus aureus
In 1 g n.d.
General
Glycine
Stability

Product is stable for 4 years from date of production if stored under recommended conditions in original packaging.

Storage

Dry and dark at room temperature in tightly closed container

Chemical data
Formula
C2H5NO2
CAS Number
56-40-6
Packaging
25 kg Unit
Outer container
Fiber drum
Outer liner
LDPE
Inner liner
LDPE
EP 9 / USP 39 oral grade
(Glycine)
Parameter
Limit
Appearance:
White or almost white crystalline powder
passes
Identity (A. IR)
passes
Test on turbidity
(10.0 % (m/V) in H2O)
≤ Ref. Susp. I
Test on colour
(10.0 % (m/V) in H2O)
≤ Y7
pH
(5.0 % (m/V) in H2O)
+5.9° to +6.4°
Related substances (HPLC)
• Glycine Anhydride
• Diglycine
• Triglycine
• each other impurity
• total of impurities
 
≤ 0.10 %
≤ 0.10 %
≤ 0.10 %
≤ 0.10 %
≤ 0.2 %
Other amino acids (AAA)
• individual impurity
• total of impurities
• Ammonium
 
≤ 0.10 %
≤ 1.0 %
≤ 0.02 %
Chlorides
≤ 70 ppm
Sulfate
≤ 65 ppm
Heavy metals (as Pb)
≤ 20 ppm
Hydrolyzable substances
passes
Loss on drying
≤ 0.2 %
Residue on ignition
≤ 0.1 %
Assay (on dry basis)
98.5 to 101.0 %
Total viable aerobic count
≤ 100 CFU/g
Moulds and yeasts
≤ 10 CFU/g
Salmonella
In 10 g n.d.
Escherichia coli
In 10 g n.d.
Pseudomonas aeruginosa
In 10 g n.d.
Staphylococcus aureus
In 10 g n.d.
L-Asparagine Anhydrous
General
L-Asparagine Anhydrous
Stability

Product is stable for 4 years from date of production if stored under recommended conditions in original packaging.

Storage

Dry and dark at room temperature in tightly closed container

Chemical data
Formula
C4H8N2O3
CAS Number
70-47-3
Packaging
25 kg Unit
Outer container
Fiber drum
Outer liner
Alu/PE comp.
Inner liner
LDPE
EP 9 infusion grade
(L-Asparagine Anhydrous)
Parameter
Limit
Appearance:
White or almost white crystalline powder or colourless crystals
passes
Identity (A. Specific optical rotation / B. IR)
passes
Test on turbidity
(2.0 % (m/V) in H2O)
≤ Ref. Susp. I
Test on colour
(2.0 % (m/V) in H2O)
≤ B9
Specific optical rotation (on dry basis)
(10.0 % (m/V) in 3M HCI at 20 °C [α]D20)
+33.7° to 36.0°
Ninhydrin-positive substances (TLC)
passes
Ammonium
≤ 0.1 %
Chlorides
≤ 200 ppm
Sulphates
≤ 200 ppm
Iron
≤ 10 ppm
Loss on drying
≤ 0.1 %
Residue on ignition
≤ 0.1 %
Assay (on dry basis)
99.0 to 101.0 %
Total viable aerobic count
≤ 100 CFU/g
Moulds and yeasts
≤ 10 CFU/g
Salmonella
In 1 g n.d.
Escherichia coli
In 1 g n.d.
Pseudomonas aeruginosa
In 1 g n.d.
Staphylococcus aureus
In 1 g n.d.
Endotoxins
< 6 EU/g
General
L-Asparagine Anhydrous
Stability

Product is stable for 4 years from date of production if stored under recommended conditions in original packaging.

Storage

Dry and dark at room temperature in tightly closed container

Chemical data
Formula
C4H8N2O3
CAS Number
70-47-3
Packaging
25 kg Unit
Outer container
Fiber drum
Outer liner
Alu/PE comp.
Inner liner
LDPE
EP 9 oral grade
(L-Asparagine Anhydrous)
Parameter
Limit
Appearance:
White or almost white crystalline powder or colourless crystals
passes
Identity (A. Specific optical rotation / B. IR)
passes
Test on turbidity
(2.0 % (m/V) in H2O)
≤ Ref. Susp. I
Test on colour
(2.0 % (m/V) in H2O)
≤ B9
Specific optical rotation (on dry basis)
(10.0 % (m/V) in 3M HCI at 20 °C [α]D20)
+33.7° to +36.0°
Ninhydrin-positive substances (TLC)
passes
Ammonium
≤ 0.1 %
Chlorides
≤ 200 ppm
Sulphates
≤ 200 ppm
Iron
≤ 10 ppm
Loss on drying
≤ 10 %
Residue on ignition
≤ 0.1 %
Assay (on dry basis)
99.0 to 101.0 %
Total viable aerobic count
≤ 1000 CFU/g
Moulds and yeasts
≤ 100 CFU/g
Salmonella
In 1 g n.d.
Escherichia coli
In 1 g n.d.
Pseudomonas aeruginosa
In 1 g n.d.
Staphylococcus aureus
In 1 g n.d.
DL-Aspartic acid
General
DL-Aspartic acid
Stability

Product is stable for 4 years from date of production if stored under recommended conditions in original packaging.

Storage

Dry and dark at room temperature in tightly closed container

Chemical data
Formula
C4H7NO4
CAS Number
617-45-8
Packaging
25 kg Unit
Outer container
Fiber drum
Outer liner
LDPE
Inner liner
LDPE
EP 9 infusion grade
(DL-Apartic acid)
Parameter
Limit
Appearance:
White or almost white crystalline powder or colourless crystals
passes
Identity (A. Specific optical rotation / B. IR)
passes
Test on turbidity
(5.0 % (m/V) in 1 M HCI)
≤ Ref. Susp. I
Test on colour
(5.0 % (m/V) in 1 M HCI)
≤ BY6
Specific optical rotation (on dry basis)
(8.0 % (m/V) in 25 % HCI at 20 °C [α]D20)
–0.1° to +0.1°
Ninhydrin-positive substances (TLC)
passes
Chlorides
≤ 200 ppm
Sulphates
≤ 300 ppm
Ammonium
≤ 200 ppm
Iron
≤ 10 ppm
Loss on drying
≤ 0.5 %
Residue on ignition
≤ 0.1 %
Assay (on dry basis)
98.5 to 101.5 %
Total viable aerobic count
≤ 100 CFU/g
Moulds and yeasts
≤ 10 CFU/g
Salmonella
In 1 g n.d.
Escherichia coli
In 1 g n.d.
Pseudomonas aeruginosa
In 1 g n.d.
Staphylococcus aeureus
In 1 g n.d.
Endotoxins (LAL-Assay)
< 8 EU/g
General
DL-Aspartic acid
Stability

Product is stable for 4 years from date of production if stored under recommended conditions in original packaging.

Storage

Dry and dark at room temperature in tightly closed container

Chemical data
Formula
C4H7NO4
CAS Number
617-45-8
Packaging
25 kg Unit
Outer container
Fiber drum
Outer liner
LDPE
Inner liner
LDPE
EP 9 oral grade
(DL-Apartic acid)
Parameter
Limit
Appearance:
White or almost white crystalline powder or colourless crystals
passes
Identitiy (IR / HPLC)
passes
Test on turbidity
(5.0 % (m/V) in 1 M HCI)
≤ Ref. Susp. I
Test on colour
(5.0 % (m/V) in 1 M HCI)
≤ BY6
Specific optical rotation (on dry basis)
(8.0 % (m/V) in 25 % HCI at 20 °C [α]D20)
+0.1° to –0.1°
Ninhydrin-positive substances (TLC)
passes
Chlorides
≤ 200 ppm
Sulphates
≤ 300 ppm
Ammonium
≤ 200 ppm
Iron
≤ 10 ppm
Loss on drying
≤ 0.5 %
Residue on ignition
≤ 0.1 %
Assay (on dry basis)
98.5 to 101.5 %
Total viable aerobic count
≤ 1000 CFU/g
Moulds and yeasts
≤ 100 CFU/g
Salmonella
In 1 g n.d.
Escherichia coli
In 1 g n.d.
Pseudomonas aeruginosa
In 1 g n.d.
Staphylococcus aureus
In 1 g n.d.
L-Alanine
General
L-Alanine
Stability

Product is stable for 4 years from date of production if stored under recommended conditions in original packaging.

Storage

Dry and dark at room temperature in tightly closed container

Chemical data
Formula
C3H7NO2
CAS Number
65-41-7
Packaging
25 kg Unit
Outer container
Fiber drum
Outer liner
LDPE
Inner liner
LDPE
EP 9 infusion grade
(L-Alanine)
Parameter
Limit
Appearance:
White or almost white crystalline powder or colourless crystals
passes
Identity (A. Specific optical rotation / B. IR)
passes
Test on turbidity
(2.5 % (m/V) in H2O)
≤ Ref. Susp. I
Test on colour
(2.5 % (m/V) in H2O)
≤ BY6
Specific optical rotation (on dry basis)
(10.0 % (m/V) in 25 % HCI at 20 °C [α]D20)
+13.5° to +15.5°
Ninhydrin-positive substances (AAA)
▪ Each impurity
▪ Total impurities
 
≤ 0.10 %
≤ 0.5 %
Ammonium
≤ 0.02 %
Chlorides
≤ 200 ppm
Sulphates
≤ 300 ppm
Iron
≤ 10 ppm
Loss on drying
≤ 0.5 %
Residue on ignition
≤ 0.1 %
Assay (on dry basis)
98.5 to 101.0 %
Total viable aerobic count
≤ 100 CFU/g
Moulds and yeasts
≤ 10 CFU/g
Salmonella
In 1 g n.d.
Escherichia coli
In 1 g n.d.
Pseudomonas aeruginosa
In 1 g n.d.
Staphylococcus aureus
In 1 g n.d.
Endotoxins (LAL-Assay)
< 6 EU/g
General
L-Alanine
Stability

Product is stable for 4 years from date of production if stored under recommended conditions in original packaging.

Storage

Dry and dark at room temperature in tightly closed container

Chemical data
Formula
C3H7NO2
CAS Number
65-41-7
Packaging
25 kg Unit
Outer container
Fiber drum
Outer liner
LDPE
Inner liner
LDPE
EP 9 oral grade
(L-Alanine)
Parameter
Limit
Appearance:
White or almost white crystalline powder or colourless crystals
passes
Identity (A. Specific optical rotation / B. IR)
passes
Test on turbidity
(2.5 % (m/V) in H2O)
≤ Ref. Susp. I
Test on colour
(2.5 % (m/V) in H2O)
≤ BY6
Specific optical rotation (on dry basis)
(10.0 % (m/V) in 25 % HCI at 20 °C [α]D20)
+13.5° to +15.5°
Ninhydrin-positive substances (AAA)
▪ Each impurity
▪ Total impurities
 
≤ 0.10 %
≤ 0.5 %
Ammonium
≤ 0.02 %
Chlorides
≤ 200 ppm
Sulphates
≤ 300 ppm
Iron
≤ 10 ppm
Loss on drying
≤ 0.5 %
Residue on ignition
≤ 0.1 %
Assay (on dry basis)
98.5 to 101.0 %
Total viable aerobic count
≤ 1000 CFU/g
Moulds and yeasts
≤ 100 CFU/g
Salmonella
In 1 g n.d.
Escherichia coli
In 1 g n.d.
Pseudomonas aeruginosa
In 1 g n.d.
Staphylococcus aureus
In 1 g n.d.
General
L-Alanine
Stability

Product is stable for 4 years from date of production if stored under recommended conditions in original packaging.

Storage

Dry and dark at room temperature in tightly closed container

Chemical data
Formula
C3H7NO2
CAS Number
65-41-7
Packaging
25 kg Unit
Outer container
Fiber drum
Outer liner
LDPE
Inner liner
LDPE
EP 9 / USP 39 oral grade
(L-Alanine)
Parameter
Limit
Appearance:
White or almost white crystalline powder or colourless crystals
passes
Identity (A. Specific optical rotation / B. IR)
passes
Test on turbidity
(2.5 % (m/V) in H2O)
≤ Ref. Susp. I
Test on colour
(2.5 % (m/V) in H2O)
≤ BY6
Specific optical rotation (on dry basis)
(10.0 % (m/V) in 25 % HCI at 20 °C [α]D20)
(10.0 % (m/V) in 6 N HCI at 25 °C [α]D25)
 
+13.5° to +15.5°
+13.7° to +15.1°
Ninhydrin-positive substances (AAA)
▪ Each impurity
▪ Total impurities
 
≤ 0.10 %
≤ 0.5 %
Organic impurities (HPLC):
▪ Maleic acid
▪ Malic acid
▪ Fumaric acid
▪ Any unspecific impurity
▪ Total unspecific impurities
 
≤ 0.05 %
≤ 0.05 %
≤ 0.05 %
≤ 0.05 %
≤ 0.20 %
Ammonium
≤ 0.02 %
Chlorides
≤ 200 ppm
Sulphates
≤ 300 ppm
Iron
≤ 10 ppm
Heavy metals (as Pb)
≤ 15 ppm
pH
(5.0 % (m/V) in H2O)
5.5 to 7.0
Loss on drying
≤ 0.2 %
Residue on ignition
≤ 0.1 %
Assay (on dry basis)
98.5 to 101.0 %
Total viable aerobic count
≤ 100 CFU/g
Moulds and yeasts
≤ 10 CFU/g
Salmonella
In 10 g n.d.
Escherichia coli
In 10 g n.d.
Pseudomonas aeruginosa
In 10 g n.d.
Staphylococcus aureus
In 10 g n.d.
General
L-Alanine
Stability

Product is stable for 4 years from date of production if stored under recommended conditions in original packaging.

Storage

Dry and dark at room temperature in tightly closed container

Chemical data
Formula
C3H7NO2
CAS Number
65-41-7
Packaging
25 kg Unit
Outer container
Fiber drum
Outer liner
LDPE
Inner liner
LDPE
USP 39 oral grade
(L-Alanine)
Parameter
Limit
Appearance:
White or almost white crystalline powder or colourless crystals
passes
Identity (A. IR)
passes
Specific optical rotation (on dry basis)
(10.0 % (m/V) in 6 N HCI at 25 °C [α]D25)
+13.7° to +15.1°
Organic impurities (HPLC):
▪ Maleic acid
▪ Malic acid
▪ Fumaric acid
▪ Any unspecific impurity
▪ Total unspecific impurities
 
≤ 0.05 %
≤ 0.05 %
≤ 0.05 %
≤ 0.05 %
≤ 0.20 %
Chlorides
≤ 500 ppm
Sulphates
≤ 300 ppm
Iron
≤ 30 ppm
Heavy metals (as Pb)
≤ 15 ppm
pH
(5.0 % (m/V) in H2O)
5.5 to 7.0
Loss on drying
≤ 0.2 %
Residue on ignition
≤ 0.15 %
Assay (on dry basis)
98.5 to 101.5 %
Total viable aerobic count
≤ 100 CFU/g
Moulds and yeasts
≤ 10 CFU/g
Salmonella
In 10 g n.d.
Escherichia coli
In 10 g n.d.
Pseudomonas aeruginosa
In 10 g n.d.
Staphylococcus aureus
In 10 g n.d.
L-Glutamine
General
L-Glutamine
Stability

Product is stable for 2 years from date of production if stored under recommended conditions in original packaging.

Storage

Dry and dark at room temperature in tightly closed container

Chemical data
Formula
C5H10N2O3
CAS Number
56-85-9
Packaging
25 kg Unit
Outer container
Fiber drum
Outer liner
HDPE
Inner liner
LDPE
USP 39 oral grade
(L-Glutamine)
Parameter
Limit
Appearance:
White or nearly white crystalline powder
passes
Identity
passes
Specific optical rotation (on dry basis)
(4.0 % (m/V) in H2O at 20 °C [α]D20)
+6.3° to +7.3°
Related substances (TLC)
passes
Chlorides
≤ 500 ppm
Sulphates
≤ 300 ppm
Iron
≤ 30 ppm
Loss on drying
≤ 0.3 %
Residue on ignition
≤ 0.3 %
Assay (on dry basis)
98.5 to 101.5 %
Total viable aerobic count
≤ 100 CFU/g
Moulds and yeasts
≤ 10 CFU/g
Salmonella
In 10 g n.d.
Escherichia coli
In 10 g n.d.
Pseudomonas aeruginosa
In 10 g n.d.
Staphylococcus aureus
In 10 g n.d.
L-Threonine
General
L-Threonine
Stability

Product is stable for 4 years from date of production if stored under recommended conditions in original packaging.

Storage

Dry and dark at room temperature in tightly closed container

Chemical data
Formula
C4H9NO3
CAS Number
72-19-5
Packaging
25 kg Unit
Outer container
Fiber drum
Outer liner
HDPE
Inner liner
LDPE
USP 39 oral grade
(L-Threonine)
Parameter
Limit
Appearance:
White crystalline powder
passes
Identity
passes
pH-value
(5.0 % (m/V) in H2O at 25 °C)
5.0 to 6.5
Specific optical rotation (on dry basis)
(6.0 % (m/V) in H2O at 25 °C [α]D25)
–29.1° to –26.7°
Ninhydrin-positive substances (TLC)
passes
Chlorides
≤ 500 ppm
Sulphates
≤ 300 ppm
Iron
≤ 30 ppm
Heavy metals (as Pb)
≤ 15 ppm
Loss on drying
≤ 0.2 %
Residue on ignition
≤ 0.4 %
Assay (on dry basis)
98.5 to 101.5 %
Residual solvents
passes
Total viable aerobic count
≤ 100 CFU/g
Moulds and yeasts
≤ 10 CFU/g
Salmonella
In 10 g n.d.
Escherichia coli
In 10 g n.d.
Pseudomonas aeruginosa
In 10 g n.d.
Staphylococcus aureus
In 10 g n.d.
General
L-Threonine
Stability

Product is stable for 4 years from date of production if stored under recommended conditions in original packaging.

Storage

Dry and dark at room temperature in tightly closed container

Chemical data
Formula
C4H9NO3
CAS Number
72-19-5
Packaging
25 kg Unit
Outer container
Fiber drum
Outer liner
HDPE
Inner liner
LDPE
EP 9 infusion grade
(L-Threonine)
Parameter
Limit
Appearance:
White or almost white crystalline powder on colourless crystals
passes
Identity (A. Specific optical rotation / B. IR)
passes
Test on turbidity
(2.5 % (m/V) in H2O)
≤ Ref. Susp. I
Test on colour
(2.5 % (m/V) in H2O)
≤ B9
ph-Value
(2.5 % (m/V) in H2O at 20 °C)
5.0 to 6.5
Specific optical rotation (on dry basis)
(6.0 % (m/V) in H2O at 20 °C [α]D20
–29.0° to –27.6°
Ninhydrin-positive substances (HPLC)
▪ Each impurity
▪ Sum of impurities
 
≤ 0.2 %
≤ 0.5 %
Ammonium
≤ 0.02 %
Chlorides
≤ 200 ppm
Sulphates
≤ 300 ppm
Iron
≤ 10 ppm
Loss on drying
≤ 0.5 %
Residue on ignition
≤ 0.1 %
Assay (on dry basis)
99.0 to 101.0 %
Total viable aerobic count
≤ 100 CFU/g
Moulds and yeasts
≤ 10 CFU/g
Salmonella
In 1 g n.d.
Escherichia coli
In 1 g n.d.
Pseudomonas aeruginosa
In 1 g n.d.
Staphylococcus aureus
In 1 g n.d.
Endotoxins (LAL-assay)
< 6 EU/g
General
L-Threonine
Stability

Product is stable for 4 years from date of production if stored under recommended conditions in original packaging.

Storage

Dry and dark at room temperature in tightly closed container

Chemical data
Formula
C4H9NO3
CAS Number
72-19-5
Packaging
25 kg Unit
Outer container
Fiber drum
Outer liner
HDPE
Inner liner
LDPE
EP 9 oral grade
(L-Threonine)
Parameter
Limit
Appearance:
White or almost white crystalline powder or colourless crystals
passes
Identity (A. Sepecific optical rotation / B. IR)
passses
Test on turbidity
(2.5 % (m/V) in H2O)
≤ Ref. Susp. I
Test on colour
(2.5 % (m/V) in H2O)
≤ B9
pH-value
(2.5 % (m/V) in H2O at 20 °C)
5.0 to 6.5
Specific optical rotation (on dry basis)
(6.0 % (m/V) in H2O at 20 °C [α]D20)
–29.0° to –27.6°
Ninhydrin-positive substances (HPLC)
▪ Each impurity
▪ Sum of impurities
 
≤ 0.2 %
≤ 0.5 %
Ammonium
≤ 0.02 %
Chlorides
≤ 200 ppm
Sulphates
≤ 300 ppm
Iron
≤ 10 ppm
Loss on drying
≤ 0.5 %
Residue on ignition
≤ 0.1 %
Assay (on dry basis)
99.0 to 101.0 %
Total viable aerobic count
≤ 1000 CFU/g
Moulds and yeasts
≤ 100 CFU/g
Salmonella
In 1 g n.d.
Escherichia coli
In 1 g n.d.
Pseudomonas aeruginosa
In 1 g n.d.
Staphylococcus aureus
In 1 g n.d.
General
L-Threonine
Stability

Product is stable for 4 years from date of production if stored under recommended conditions in original packaging

Storage

Dry and dark at room temperature in tightly closed container

Chemical data
Formula
C4H9NO3
CAS Number
72-19-5
Packaging
25 kg Unit
Outer container
Fiber drum
Outer liner
HDPE
Inner liner
LDPE
EP 9 / USP 39 oral grade
(L-Threonine)
Parameter
Limit
Appearance:
White crystalline powder or colourless flakes
passes
Identity (A. Specific optical rotation / B. IR)
passes
Test on turbidity
(2.5 % (m/V) in H2O)
≤ Ref. Susp. I
Test on colour
(2.5 % (m/V) in H2O)
≤ B9
pH-value
(2.5 % (m/V) in H2O at 20 °C)
(5.0 % (m/V) in H2O at 25 °C)
 
5.0 to 6.5
5.0 to 6.5
Specific optical rotation (on dry basis)
(6.0 % (m/V) in H2O at 20 °C [α]D20)
(6.0 % (m/V) in H2O at 20 °C [α]D20)
 
–27.6° to –29.0°
–26.7° to –29.1°
Ninhydrin-positive substances (TLC)
passes
Ninhydrin-positive substances (HPLC)
▪ Each impurity
▪ Sum of impurities
 
≤ 0.2 %
≤ 0.5 %
Ammonium
≤ 0.02 %
Chlorides
≤ 200 ppm
Sulphates
≤ 300 ppm
Iron
≤ 10 ppm
Heavy metals (as Pb)
≤ 15 ppm
Loss on drying
≤ 0.2 %
Residue on ignition
≤ 0.1 %
Assay (on dry basis)
99.0 to 101.0 %
Residual solvents
passes
Total viable aerobic count
≤ 100 CFU/g
Moulds and yeasts
≤ 10 CFU/g
Salmonella
In 10 g n.d.
Escherichia coli
In 10 g n.d.
Pseudomonas aeruginosa
In 10 g n.d.
Staphylococcus aureus
In 10 g n.d.
L-Serine
General
L-Serine
Stability

Product is stable for 4 years from date of production if stored under recommended conditions in original packaging.

Storage

Dry and dark at room temperature in tightly closed container

Chemical data
Formula
C3H7NO3
CAS Number
56-45-1
Packaging
25 kg Unit
Outer container
Fiber drum
Outer liner
Alu/PE comp.
Inner liner
LDPE
USP 39 oral grade
(L-Serine)
Parameter
Limit
Appearance:
White crystalline powder
passes
Identity
passes
Specific optical rotation (on dry basis)
(10.0 % (m/V) in 2 N HCI at 25 °C [α]D25
+14.0° to +15.6°
Ninhydrin-positive substances (TLC)
passes
Chlorides
≤ 500 ppm
Sulphates
≤ 300 ppm
Iron
≤ 30 ppm
Heavy metals (as Pb)
≤ 15 ppm
Loss on drying
≤ 0.2 %
Residue on ignition
≤ 0.1 %
Assay (on dry basis)
98.5 to 101.5 %
Residual solvents
passes
Total viable aerobic count
≤ 100 CFU/g
Moulds and yeasts
≤ 10 CFU/g
Salmonella
In 10 g n.d.
Escherichia coli
In 10 g n.d.
Pseudomonas aeruginosa
In 10 g n.d.
Staphylococcus aureus
In 10 g n.d.
General
L-Serine
Stability

Product is stable for 4 years from date of production if stored under recommended conditions in original packaging.

Storage

Dry and dark at room temperature in tightly closed container

Chemical data
Formula
C3H7NO3
CAS Number
56-45-1
Packaging
25 kg Unit
Outer container
Fiber drum
Outer liner
Alu/PE comp.
Inner liner
LDPE
EP 9 infusion grade
(L-Serine)
Parameter
Limit
Appearance:
White or almost white crystalline powder or colourless crystals
passes
Identity (A. Specific optical rotation / B. IR)
passes
Test on turbidity
(5.0 % (m/V) in H2O)
≤ Ref. Susp. I
Test on colour
(5.0 % (m/V) in H2O)
≤ BY6
Specific optical rotation (on dry basis)
(10.0 % (m/V) in 2 M HCI at 20 °C [α]D20)
+14.0° to +16.0°
Ninhydrin-positive substance (HPLC)
▪ Each impurity
▪ Sum of impurities
 
≤ 0.2 %
≤ 0.5 %
Ammonium
≤ 0.02 %
Chlorides
≤ 200 ppm
Sulphates
≤ 300 ppm
Iron
≤ 10 ppm
Loss on drying
≤ 0.5 %
Residue on ignition
≤ 0.1 %
Assay (on dry basis)
98.5 to 101.0 %
Total viable aerobic count
≤ 100 CFU/g
Moulds and yeasts
≤ 10 CFU/g
Salmonella
In 1 g n.d.
Escherichia coli
In 1 g n.d.
Pseudomonas aeruginosa
In 1 g n.d.
Staphylococcus aureus
In 1 g n.d.
Endotoxins (LAL-assay)
< 6 EU/g
General
L-Serine
Stability

Product is stable for 4 years from date of production if stored under recommended conditions in original packaging.

Storage

Dry and dark at room temperature in tightly closed container

Chemical data
Formula
C3H7NO3
CAS Number
56-45-1
Packaging
25 kg Unit
Outer container
Fiber drum
Outer liner
Alu/PE comp.
Inner liner
LDPE
EP 9 oral grade
(L-Serine)
Parameter
Limit
Appearance:
White or almost white crystalline powder or colourless crystals
passes
Identity (A. Specific optical rotation / B. IR)
passes
Test on turbidity
(5.0 % (m/V) om H2O)
≤ Ref. Susp. I
Test on colour
(5.0 % (m/V) in H2O)
≤ BY6
Specific optical rotation (on dry basis)
(10.0 % (m/V) in 2 M HCI at 20 °C [α]D20)
+14.0° to +16.0°
Ninhydrin-positive substances (HPLC)
▪ Each impurity
▪ Sum of impurities
 
≤ 0.2 %
≤ 0.5 %
Ammonium
≤ 0.02 %
Chlorides
≤ 200 ppm
Sulphates
≤ 300 ppm
Iron
≤ 10 ppm
Loss on drying
≤ 0.5 %
Residue on ignition
≤ 0.1 %
Assay (on dry basis)
98.5 to 101.0 %
Total viable aerobic count
≤ 1000 CFU/g
Moulds and yeasts
≤ 100 CFU/g
Salmonella
In 1 g n.d.
Escherichia coli
In 1 g n.d.
Pseudomonas aeruginosa
In 1 g n.d.
Staphylococcus aureus
In 1 g n.d.
General
L-Serine
Stability

Product is stable for 4 years from date of production if stored under recommended conditions in original packaging.

Storage

Dry and dark at room temperature in tightly closed container

Chemical data
Formula
C3H7NO3
CAS Number
56-45-1
Packaging
25 kg Unit
Outer container
Fiber drum
Outer liner
Alu/PE comp.
Inner liner
LDPE
EP 9 / USP 39 oral grade
(L-Serine)
Parameter
Limit
Appearance:
White crystalline powder
passes
Identity (A. Specific optical rotation / B. IR)
passes
Test on turbidity
(5.0 % (m/V) in H2O)
≤ Ref. Susp. I
Test on colour
(5.0 % (m/V) in H2O)
≤ BY6
Specific optical rotation (on dry basis)
(10.0 % (m/V) in 2 M HCI at 20 °C [α]D20)
(10.0 % (m/V) in 2 M HCI at 25 °C [α]D25)
 
+14.0° to +16.0°
+14.0° to +15.6°
Ninhydrine-positive substances (TLC)
passes
Ninhydrine-positive substances (HPLC)
▪ Each impurity
▪ Sum of impurities
 
≤ 0.2 %
≤ 0.5 %
Ammonium
≤ 0.02 %
Chlorides
≤ 200 ppm
Sulphates
≤ 300 ppm
Iron
≤ 10 ppm
Heavy metals
≤ 15 ppm
Loss on drying
≤ 0.2 %
Residue on ignition
≤ 0.1 %
Assay (on dry basis)
98.5 to 101.0 %
Residual solvents
passes
Total viable aerobic count
≤ 100 CFU/g
Moulds and yeasts
≤ 10 CFU/g
Salmonella
In 10 g n.d.
Escherichia coli
In 10 g n.d.
Pseudomonas aeruginosa
In 10 g n.d.
Staphylococcus aureus
In 10 g n.d.
L-Glutamic acid
General
L-Glutamic acid
Stability

Product is stable for 4 years from date of production if stored under recommended conditions in original packaging.

Storage

Dry and dark at room temperature in tightly closed container

Chemical data
Formula
C5H9NO4
CAS Number
56-86-0
Packaging
25 kg Unit
Outer container
Fiber drum
Outer liner
LDPE
Inner liner
LDPE
EP 9 infusion grade
(L-Glutamic acid)
Parameter
Limit
Appearance:
White or almost white crystalline powder or colourless crystals
passes
Identity (A. Specific optical rotation / B. IR)
passes
Test on turbidity
(10.0 % (m/V) in 1 M HCI)
≤ Ref. Susp. I
Test on colour
(10.0 % (m/V) in 1 M HCI)
≤ B9
Specific optical rotation (on dry basis)
(10.0 % (m/V) in 1 M HCI at 20 °C [α]D20)
+30.5° to +32.5°
Ninhydrin-positive substances (TLC)
≤ 0.5 %
Chlorides
≤ 200 ppm
Sulphates
≤ 300 ppm
Ammonium
≤ 200 ppm
Iron
≤ 10 ppm
Loss on drying
≤ 0.5 %
Residue on ignition
≤ 0.1 %
Assay (on dry basis)
98.5 to 101.5 %
Total viable aerobic count
≤ 100 CFU/g
Moulds and yeasts
≤ 10 CFU/g
Salmonella
In 1 g n.d.
Escherichia coli
In 1 g n.d.
Pseudomonas aeruginosa
In 1 g n.d.
Staphylococcus aureus
In 1 g n.d.
Endotoxins (LAL-assay)
< 6 EU/g
General
L-Glutamic acid
Stability

Product is stable for 4 years from date of production if stored under recommended conditions in original packaging.

Storage

Dry and dark at room temperature in tightly closed container

Chemical data
Formula
C5H9NO4
CAS Number
56-86-0
Packaging
25 kg Unit
Outer container
Fiber drum
Outer liner
LDPE
Inner liner
LDPE
EP 9 oral grade
(L-Glutamic acid)
Parameter
Limit
Appearance:
White or almost white crystalline powder or colourless crystals
passes
Identity (A. Specific optical rotation / B. IR)
passes
Test on turbidity
(10.0 % (m/V) in 1 M HCI)
≤ Ref. Susp. I
Test on colour
(10.0 % (m/V) in 1 M HCI)
≤ B9
Specific optical rotation (on dry basis)
(10.0 % (m/V) in 1 M HCI at 20 °C [α]D20)
+30.5° to 32.5°
Ninhydrin-positive substances (TLC)
≤ 0.5 %
Chlorides
≤ 200 ppm
Sulphates
≤ 300 ppm
Ammonium
≤ 200 ppm
Iron
≤ 10 ppm
Loss on drying
≤ 0.5 %
Residue on ignition
≤ 0.1 %
Assay (on dry basis)
98.5 to 101.5 %
Total viable aerobic count
≤ 1000 CFU/g
Moulds and yeasts
≤ 100 CFU/g
Salmonella
In 1 g n.d.
Escherichia coli
In 1 g n.d.
Pseudomonas aeruginosa
In 1 g n.d.
Staphylococcus aureus
In 1 g n.d.
N-Acetyl-L-Methionine
General
N-Acetyl-L-Methionine
Stability

Product is stable for 4 years from date of production if stored under recommended conditions in original packaging.

Storage

Dry and dark at room temperature in tightly closed container

Chemical data
Formula
C7H13NO3S
CAS Number
65-82-7
Packaging
25 kg Unit
Outer container
Fiber drum
Outer liner
LDPE
Inner liner
LDPE
Oral grade
(N-Acetyl-L-Methionine)
Parameter
Limit
Appearance:
White crystals or white crystalline powder
passes
Identity
passes
Specific optical rotation (on dry basis)
(5.0 % (m/V) in H2O at 20 °C [α]D20)
–22.0° to –19.0°
Ninhydrin-positive substances (TLC)
≤ 0.5 %
Chlorides
≤ 200 ppm
Ammonium
≤ 200 ppm
Sulphates
≤ 300 ppm
Iron
≤ 20 ppm
Heavy metals (as Pb)
≤ 10 ppm
Loss on drying
≤ 0.3 %
Sulphated ash
≤ 0.1 %
Assay (on dry basis)
99.0 to 101.0 %
Total viable aerobic count
< 1000 CFU/g
Moulds and yeasts
< 100 CFU/g
Salmonella
In 10 g n.d.
Escherichia coli
In 10 g n.d.
Pseudomonas aeruginosa
In 10 g n.d.
Staphylococcus aureus
In 10 g n.d.
L-Asparagine Monohydrate
General
L-Asparagine Monohydrate
Stability

Product is stable for 4 years from date of production if stored under recommended conditions in original packaging.

Storage

Dry and dark at room temperature in tightly closed container

Chemical data
Formula
C4H8N2O3*H2O
CAS Number
5794-13-8
Packaging
25 kg Unit
Outer container
Fiber drum
Outer liner
LDPE
Inner liner
LDPE
EP 9 infusion grade
(L-Asparagine Monohydrate)
Parameter
Limit
Appearance:
White or almost white crystalline powder or colourless crystals
passes
Identity (A. Specific optical rotation / B. IR)
passes
Test on turbidity
(2.0 % (m/V) in H2O)
≤ Ref. Susp. I
Test on colour
(2.0 % (m/V) in H
≤ B9
Specific optical rotation (on dry basis)
(10.0 % (m/V) in 3 M HCI at 20 °C [α]D20)
+33.7° to +36.0°
Ninhydrin-positive substances (TLC)
passes
Other amino acids (HPLC):
▪ Aspartic Acid
▪ Glumatic Acid
▪ Any unspecific impurity
▪ Total impurities
 
≤ 0.5 %
≤ 0.5 %
≤ 0.05 %
≤ 0.5 %
pH
(2 % (m/V) in H2O)
4.0 to 6.0
Chlorides
≤ 200 ppm
Sulphates
≤ 200 ppm
Ammonium
≤ 0.1 %
Iron
≤ 10 ppm
Loss on drying
10.5 % to 12.5 %
Residue on ignition
≤ 0.1 %
Assay (on dry basis)
99.0 to 101.0 %
Total viable aerobic count
≤ 100 CFU/g
Moulds and yeasts
≤ 10 CFU/g
Salmonella
In 1 g n.d.
Escherichia coli
In 1 g n.d.
Pseudomonas aeruginosa
In 1 g n.d.
Staphylococcus aureus
In 1 g n.d.
Endotoxins
< 6 EU/g
General
L-Asparagine Monohydrate
Stability

Product is stable for 4 years from date of production if stored under recommended conditions in original packaging

Storage

Dry and dark at room temperature in tightly closed container

Chemical data
Formula
C4H8N2O3*H2O
CAS Number
5794-13-8
Packaging
25 kg Unit
Outer container
Fiber drum
Outer liner
LDPE
Inner liner
LDPE
EP 9 / NF 34 oral grade
(L-Asparagine Monohydrate)
Parameter
Limit
Appearance:
White or almost white crystalline powder or colourless crystals
passes
Identity (A. Specific optical rotation / B. IR)
passes
Test on turbidity
(2.0 % (m/V) in H2O)
≤ Ref. Susp. I
Test on colour
(2.0 % (m/V) in H2O)
≤ B9
Specific optical rotation (on dry basis)
(10.0 % (m/V) in 3 M HCI at 20 °C [&alpha]D20)
(1.0 % (m/V) in 6 M HCI at 20 °C [&alpha]D20)
 
+33.7° to +36.0°
+33.0° to +36.5°
Ninhydrin-positive substances (TLC)
passes
Other amino acids (HPLC):
▪ Aspartic Acid
▪ Glutamic Acid
▪ Any unspecific impurity
▪ Total impurities
 
≤ 0.5 %
≤ 0.5 %
≤ 0.05 %
≤ 0.5 %
pH
(2 % (m/V) in H2O)
4.0 to 6.0
Chlorides
≤ 200 ppm
Sulphates
≤ 200 ppm
Ammonium
≤ 0.1 %
Iron
≤ 10 ppm
Lead
≤ 5 ppm
Loss on drying
11.5 % to 12.5 %
Residue on ignition
≤ 0.1 %
Assay (on dry basis)
99.0 to 101.0 %
Total viable aerobic count
≤ 1000 CFU/g
Moulds and yeasts
≤ 100 CFU/g
Bile-tolerant gram-negative bacteria
In 1 g n.d.
Salmonella
In 1 g n.d.
Escherichia coli
In 1 g n.d.
Pseudomonas aeruginosa
In 1 g n.d.
Staphylococcus aureus
In 1 g n.d.
Clostridia
In 1 g n.d.
Candida albicans
In 1 g n.d.
General
L-Asparagine Monohydrate
Stability

Product is stable for 4 years from date of production if stored under recommended conditions in original packaging

Storage

Dry and dark at room temperature in tightly closed container

Chemical data
Formula
C4H8N2O3*H2O
CAS Number
5794-13-8
Packaging
25 kg Unit
Outer container
Fiber drum
Outer liner
LDPE
Inner liner
LDPE
NF 34 oral grade
(L-Asparagine Monohydrate)
Parameter
Limit
Identitiy (Method B)
passes
Specific optical rotation (on dry basis)
(10.0 mg/ml in 6 M HCI at 20 °C [α]D20)
+33.0° to +36.5°
Ninhydrin-positive substances (TLC)
passes
Lead
≤ 5 ppm
Loss on drying
11.5 % to 12.5 %
Residue on ignition
≤ 0.1 %
Assay (on dry basis)
98.0 to 101.5 %
Total viable aerobic count
≤ 1000 CFU/g
Moulds and yeasts
≤ 100 CFU/g
Bile-tolerant gram-negative bacteria
In 1 g n.d.
Salmonella
In 1 g n.d.
Escherichia coli
In 10 g n.d.
Pseudomonas aeruginosa
In 1 g n.d.
Staphylococcus aureus
In 1 g n.d.
Clostridia
In 1 g n.d.
Candida albicans
In 1 g n.d.
General
L-Asparagine Monohydrate
Stability

Product is stable for 4 years from date of production if stored under recommended conditions in original packaging.

Storage

Dry and dark at room temperature in tightly closed container

Chemical data
Formula
C4H8N2O3*H2O
CAS Number
5794-13-8
Packaging
25 kg Unit
Outer container
Fiber drum
Outer liner
LDPE
Inner liner
LDPE
EP 9 oral grade
(L-Asparagine Monohydrate)
Parameter
Limit
Appearance:
White or almost white crystalline powder or colourless crystals
passes
Identity (A. Specific optical rotation / B. IR)
passes
Test on turbidity
(2.0 % (m/V) in H2O)
≤ Ref. Susp. I
Test on colour
(2.0 % (m/V) in H2O)
≤ B9
Specific optical rotation (on dry basis)
(10.0 % (m/V) in 3 M HCI at 20 °C [&alpha]D20)
+33.7° to +36.0°
Ninhydrin-positive substances (TLC)
passes
Other amino acids (HPLC):
▪ Aspartic Acid
▪ Glutamic Acid
▪ Any unspecific impurity
▪ Total impurities
 
≤ 0.5 %
≤ 0.5 %
≤ 0.05 %
≤ 0.5 %
pH
(2 % (m/V) in H2O)
4.0 to 6.0
Chlorides
≤ 200 ppm
Sulphates
≤ 200 ppm
Ammonium
≤ 0.1 %
Iron
≤ 10 ppm
Loss on drying
10.5 % to 12.5 %
Residue on ignition
≤ 0.1 %
Assay (on dry basis)
99.0 to 101.0 %
Total viable aerobic count
≤ 1000 CFU/g
Moulds and yeasts
≤ 100 CFU/g
Salmonella
In 1 g n.d.
Escherichia coli
In 1 g n.d.
Pseudomonas aeruginosa
In 1 g n.d.
Staphylococcus aureus
In 1 g n.d.
L-Aspartic acid
General
L-Aspartic acid
Stability

Product is stable for 4 years from date of production if stored under recommended conditions in original packaging.

Storage

Dry and dark at room temperature in tightly closed container

Chemical data
Formula
C4H7NO4
CAS Number
56-84-8
Packaging
25 kg Unit
Outer container
Fiber drum
Outer liner
LDPE
Inner liner
LDPE
EP 9 infusion grade
(L-Aspartic acid)
Parameter
Limit
Appearance:
White or almost white crystalline powder or colourless crystals
passes
Identity (A. Specific optical rotation / B. IR)
passes
Test on turbidity
(5.0 % (m/V) in 1 M HCI)
≤ Ref. Susp. I
Test on colour
(5.0 % (m/V) in 1 M HCI)
≤ BY6
Specific optical rotation (on dry basis)
(8.0 % (m/V) n 25 % HCI at 20 °C [α]D20)
+24.0° to +26.0°
Ninhydrin-positive substances (TLC)
passes
Other amino acids (AAA):
▪ Asparagine
▪ Any other amino acid
▪ Sum of other amino acids
 
≤ 0.1 %
≤ 0.05 %
≤ 0.5 %
Chlorides
≤ 200 ppm
Sulphates
≤ 300 ppm
Ammonium
≤ 200 ppm
Iron
≤ 10 ppm
Loss on drying
≤ 0.5 %
Residue on ignition
≤ 0.1 %
Assay (on dry basis)
98.5 to 101.5 %
Total viable aerobic count
≤ 100 CFU/g
Moulds and yeasts
≤ 10 CFU/g
Salmonella
In 1 g n.d.
Escherichia coli
In 1 g n.d.
Pseudomonas aeruginosa
In 1 g n.d.
Staphylococcus aureus
In 1 g n.d.
Endotoxins (LAL-Assay)
< 6 EU/g
General
L-Aspartic acid
Stability

Product is table for 4 years from date of production if stored under recommended conditions in original packaging

Storage

Dry and dark at room temperature in tightly closed container

Chemical data
Formula
C4H7NO4
CAS Number
56-84-8
Packaging
25 kg Unit
Outer container
Fiber drum
Outer liner
LDPE
Inner liner
LDPE
USP 38 oral grade
(L-Aspartic acid)
Parameter
Limit
Appearance:
White powder or colourless crystals
passes
Identity (A. IR)
passes
Specific optical rotation (on dry basis)
(8.0 % (m/V) in 6 N HCI at 20 °C [α]D20)
+24.0° to +26.0°
Ninhydrin-positive substances (TLC)
▪ of any individual impurity
≤ 0.5 %
Chlorides
≤ 200 ppm
Sulphates
≤ 300 ppm
Iron
≤ 10 ppm
Heavy metals (as Pb)
≤ 10 ppm
Loss on drying
≤ 0.5 %
Residue on ignition
≤ 0.1 %
Assay (on dry basis)
98.5 to 101.5 %
Residual solvents
passes
Total viable aerobic count
≤ 100 CFU/g
Moulds and yeasts
≤ 10 CFU/g
Salmonella
In 10 g n.d.
Escherichia coli
In 10 g n.d.
Pseudomonas aeruginosa
In 10 g n.d.
Staphylococcus aureus
In 10 g n.d.
General
L-Aspartic acid
Stability

Product is stable for 4 years from date of production if stored under recommended conditions in original packaging.

Storage

Dry and dark at room temperature in tightly closed container

Chemical data
Formula
C4H7NO4
CAS Number
56-84-8
Packaging
25 kg Unit
Outer container
Fiber drum
Outer liner
LDPE
Inner liner
LDPE
EP 9 oral grade
(L-Aspartic acid)
Parameter
Limit
Appearance:
White or almost white crystalline powder or colourless crystals
passes
Identity (A. Specific optical rotation / B. IR)
passes
Test on turbidity
(5.0 % (m/V) in 1 M HCI)
≤ Ref. Susp. I
Test on colour
(5.0 % (m/V) in 1 M HCI)
≤ BY6
Specific optical rotation (on dry basis)
(8.0 % (m/V) in 25 % HCI at 20 °C [α]D20)
+24.0° to +26.0°
Ninhydrin-positive substances (TLC)
passes
Other amino acids (AAA):
▪ Asparagine
▪ Any other amino acid
▪ Sum of other amino acids
 
≤ 0.1 %
≤ 0.05 %
≤ 0.5 %
Chlorides
≤ 200 ppm
Sulphates
≤ 300 ppm
Ammonium
≤ 200 ppm
Iron
≤ 10 ppm
Loss on drying
≤ 0.5 %
Residue on ignition
≤ 0.1 %
Assay (on dry basis)
98.5 to 101.5 %
Total viable aerobic count
≤ 1000 CFU/g
Moulds and yeasts
≤ 100 CFU/g
Salmonella
In 1 g n.d.
Escherichia coli
In 1 g n.d.
Pseudomonas aeruginosa
In 1 g n.d.
Staphylococcus aureus
In 1 g n.d.
General
L-Aspartic acid
Stability

Product is stable for 4 years from date of production if stored under recommended conditions in original packaging.

Storage

Dry and dark at room temperature in tightly closed container

Chemical data
Formula
C4H7NO4
CAS Number
56-84-8
Packaging
25 kg Unit
Outer container
Fiber drum
Outer liner
LDPE
Inner liner
LDPE
EP 9 / USP 38 oral grade
(L-Aspartic acid)
Parameter
Limit
Appearance:
White or almost white crystalline powder or colourless crystals
passes
Identity (A. Specific optical rotation / B. IR)
passes
Test on turbidity
(5.0 % (m/V) in 1 M HCI)
≤ Ref. Susp. I
Test on colour
(5.0 % (m/V) in 1 M HCI)
≤ BY6
Specific optical rotation (on dry basis)
(8.0 % (m/V) in 25 % HCI at 20 °C [α]D20)
(8.0 % (m/V) in 6 N HCI at 20 °C [α]D20)
 
+24.0° to +26.0°
+24.0° to +26.0°
Ninhydrin-positive substances (TLC)
passes
Other amino acids (AAA):
▪ Asparagine
▪ Any other amino acid
▪ Sum of other amino acids
 
≤ 0.1 %
≤ 0.05 %
≤ 0.5 %
Chlorides
≤ 200 ppm
Sulphates
≤ 300 ppm
Ammonium
≤ 200 ppm
Iron
≤ 10 ppm
Heavy metals (as Pb)
≤ 10 ppm
Loss on drying
≤ 0.5 %
Residue on ignition
≤ 0.1 %
Assay (on dry basis)
98.5 to 101.5%
Total viable aerobic count
≤ 100 CFU/g
Moulds and yeasts
≤ 10 CFU/g
Salmonella
In 10 g n.d.
Escherichia coli
In 10 g n.d.
Pseudomonas aeruginosa
In 10 g n.d.
Staphylococcus aureus
In 10 g n.d.
L-Tryptophan
General
L-Tryptophan
Stability

Product is stable for 4 years from date of production if stored under recommended conditions in original packaging.

Storage

Dry and dark at room temperature in tightly closed container

Chemical data
Formula
C11H12N2O2
CAS Number
73-22-3
Packaging
25 kg Unit
Outer container
Fiber drum
Outer liner
LDPE
Inner liner
LDPE
EP 9 infusion grade
(L-Tryptophan)
Parameter
Limit
Appearance:
White or almost white crystalline or amorphous powder
passes
Identity
passes
Test on turbidity
(1.0 % (m/V) in 1 M HCI)
≤ Ref. Susp. I
Test on colour
(1.0 % (m/V) in 1 M HCI)
≤ BY6
Specific optical rotation (on dry basis)(1.0 % (m/V) in H2O at 20 °C [α]D20)
–33.0° to –30.0°
Ninhydrin-positive substances (HPLC)
▪ Each impurity
▪ Sum of impurities
 
≤ 0.2 %
≤ 0.5 %
Related substances (HPLC)
▪ Sum of peaks with RT < Trp
▪ Sum of peaks with RT > Trp
▪ Ethylidenditryptophan (Peak E)
 
≤ 100 ppm
≤ 300 ppm
≤ 10 ppm
Ammonium
≤ 0.02 %
Chlorides
≤ 200 ppm
Sulphates
≤ 300 ppm
Iron
≤ 20 ppm
Loss on drying
≤ 0.5 %
Residue on ignition
≤ 0.1 %
Assay (on dry basis)
98.5 to 101.0 %
Total viable aerobic count
≤ 100 CFU/g
Moulds and yeasts
≤ 10 CFU/g
Salmonella
In 1 g n.d.
Escherichia coli
In 1 g n.d.
Pseudomonas aeruginosa
In 1 g n.d.
Staphylococcus aureus
In 1 g n.d.
Endotoxins (LAL-assay)
< 6 EU/g
General
L-Tryptophan
Stability

Product is stable for 4 years from date of production if stored under recommended conditions in original packaging.

Storage

Dry and dark at room temperature in tightly closed container

Chemical data
Formula
C11H12N2O2
CAS Number
73-22-3
Packaging
25 kg Unit
Outer container
Fiber drum
Outer liner
LDPE
Inner liner
LDPE
USP 39 oral grade
(L-Tryptophan)
Parameter
Limit
Appearance:
White or yellowish-white crystalline powder or colourless crystals
passes
Identity
passes
pH-value
(1.0 % (m/V) in H2O at 25 °C)
5.5 to 7.0
Specific optical rotation (on dry basis)
(1.0 % (m/V) in H2O at 25 °C [α]D25
–32.8° to –29.4°
Related substances (HPLC)
▪ Total impurities eluting prior Trp
▪ Total impurities eluting after Trp
▪ Ethylidenditryptophan (Peak E)
 
≤ 100 ppm
≤ 300 ppm
≤ 10 ppm
Chlorides
≤ 500 ppm
Sulphates
≤ 300 ppm
Iron
≤ 30 ppm
Heavy metals (as Pb)
≤ 15 ppm
Loss on drying
≤ 0.3 %
Residue on ignition
≤ 0.1 %
Assay (on dry basis)
98.5 to 101.5 %
Residual solvents
passes
Total viable aerobic count
≤ 100 CFU/g
Moulds and yeasts
≤ 10 CFU/g
Salmonella
In 10 g n.d.
Escherichia coli
In 10 g n.d.
Pseudomonas aeruginosa
In 10 g n.d.
Staphylococcus aureus
In 10 g n.d.
General
L-Tryptophan
Stability

Product is stable for 4 years from date of production if stored under recommended conditions in original packaging.

Storage

Dry and dark at room temperature in tightly closed container

Chemical data
Formula
C11H12N2O2
CAS Number
73-22-3
Packaging
25 kg Unit
Outer container
Fiber drum
Outer liner
LDPE
Inner liner
LDPE
EP 9 oral grade
(L-Tryptophan)
Parameter
Limit
Appearance:
White or almost white crystalline or amorphous powder
passes
Identity
passes
Test on turbidity
(1.0 % (m/V) in 1 M HCI)
≤ Ref. Susp. I
Test on colour
(1.0 % (m/V) in 1 M HCI)
≤ BY6
Specific optical rotation (on dry basis)
(1.0 % (m/V) in H2O at 20 °C [α]D20)
–33.0° to –30.0°
Ninhydrin-positive substances (HPLC)
▪ Each impurity
▪ Sum of impurities
 
≤ 0.2 %
≤ 0.5 %
Related substances (HPLC)
▪ Sum of peaks eluting prior to Trp
▪ Sum of peaks eluting after Trp
▪ Ethylidenditryptophan (Peak E)
 
≤ 100 ppm
≤ 300 ppm
≤ 10 ppm
Ammonium
≤ 0.02 %
Chlorides
≤ 200 ppm
Sulphates
≤ 300 ppm
Iron
≤ 20 ppm
Loss on drying
≤ 0.5 %
Residue on ignition
≤ 0.1 %
Assay (on dry basis)
98.5 to 101.0 %
Total viable aerobic count
≤ 1000 CFU/g
Moulds and yeasts
≤ 100 CFU/g
Salmonella
In 1 g n.d.
Escherichia coli
In 1 g n.d.
Pseudomonas aeruginosa
In 1 g n.d.
Staphylococcus aureus
In 1 g n.d.
General
L-Tryptophan
Stability

Product is stable for 4 years from date of production if stored under recommended conditions in original packaging.

Storage

Dry and dark at room temperature in tightly closed container

Chemical data
Formula
C11H12N2O2
CAS Number
73-22-3
Packaging
25 kg Unit
Outer container
Fiber drum
Outer liner
LDPE
Inner liner
LDPE
EP 9 / USP 39 oral grade
(L-Tryptophan)
Parameter
Limit
Appearance:
White or almost white crystalline or amorphous powder
passes
Identity
passes
Test on turbidity
(1.0 % (m/V) in 1 M HCI)
≤ Ref. Susp. I
Test on colour
(1.0 % (m/V) in 1 M HCI)
≤ BY6
pH-value
(1.0 % (m/V) in H2O at 25 °C)
5.5 to 7.0
Specific optical rotation (on dry basis)
(1.0 % (m/V) in H2O at 20 °C [α]D20)
(1.0 % (m/V) in H2O at 25 °C [α]D25)
 
–33.0° to –30.0°
–32.8° to –29.4°
Ninhydrin-positive substances (TLC)
passes
Ninhydrin-positive substances (HPLC)
▪ Each impurity
▪ Sum of impurities
 
≤ 0.2 %
≤ 0.5 %
Related substances (HPLC)
▪ Sum of peaks eluting prior to Trp
▪ Sum of peaks eluting after Trp
▪ Ethylidenditryptophan (Peak E)
 
≤ 100 ppm
≤ 300 ppm
≤ 10 ppm
Ammonium
≤ 0.02 %
Chlorides
≤ 200 ppm
Sulphates
≤ 300 ppm
Iron
≤ 20 ppm
Heavy metals (as Pb)
≤ 15 ppm
Loss on drying
≤ 0.3 %
Residue on ignition
≤ 0.1 %
Assay (on dry basis)
98.5 to 101.0 %
Residual solvents
passes
Total viable aerobic count
≤ 100 CFU/g
Moulds and yeasts
≤ 10 CFU/g
Salmonella
In 10 g n.d.
Escherichia coli
In 10 g n.d.
Pseudomonas aeruginosa
In 10 g n.d.
Staphylococcus aureus
In 10 g n.d.
L-Isoleucine
General
L-Isoleucine
Stability

Products is stable for 4 years from date of production if stored under recommended conditions in original packaging.

Storage

Dry and dark at room temperature in tightly closed container

Chemical data
Formula
C6H13NO2
CAS Number
73-32-5
Packaging
25 kg Unit
Outer container
Fiber drum
Outer liner
LDPE
Inner liner
LDPE
EP 9 oral grade
(L-Isoleucine)
Parameter
Limit
Appearance:
White or almost white crystalline powder or flakes
passes
Identity (A. specific optical rotation / B. IR)
passes
Test on turbidity
(5.0 % (m/V) in 1 M HCI)
≤ Ref. Susp. I
Test on colour
(5.0 % (m/V) in 1 M HCI)
≤ BY6
Specific optical rotation (on dry basis)
(4.0 % (m/V) in 25 % HCI at 20 °C [α]D20)
+40.0° to +43.0°
Ninhydrin-positive substances (HPLC)
▪ L-Leucine
▪ L-Valine
▪ Each impurity
▪ Sum of impurities
 
≤ 0.3 %
≤ 0.3 %
≤ 0.2 %
≤ 1.0 %
Ammonium
≤ 0.02 %
Chlorides
≤ 200 ppm
Sulphates
≤ 300 ppm
Iron
≤ 10 ppm
Loss on drying
≤ 0.5 %
Residue on ignition
≤ 0.1 %
Assay (on dry basis)
98.5 to 101.0 %
Total viable aerobic count
≤ 1000 CFU/g
Moulds and yeasts
≤ 100 CFU/g
Salmonella
In 1 g n.d.
Escherichia coli
In 1 g n.d.
Pseudomonas aeruginosa
In 1 g n.d.
Staphylococcus aureus
In 1 g n.d.
General
L-Isoleucine
Stability

Product is stable for 4 years from date of production if stored under recommended conditions in original packaging.

Storage

Dry and dark at room temperature in tightly closed container

Chemical data
Formula
C6H13NO2
CAS Number
73-32-5
Packaging
25 kg Unit
Outer container
Fiber drum
Outer liner
LDPE
Inner liner
LDPE
USP 39 oral grade
(L-Isoleucine)
Parameter
Limit
Appearance:
White crystalline powder
passes
Identity
passes
pH
(1.0 % (m/V) in H2O at 25 °C)
5.5 to 7.0
Specific optical rotation (on dry basis)
(4.0 % (m/V) in 6 M HCI at 25 °C [α]D25)
+38.9° to +41.8°
Ninhydrin-positive substances (TLC)
passes
Chlorides
≤ 500 ppm
Sulphates
≤ 300 ppm
Iron
≤ 30 ppm
Heavy metals (as Pb)
≤ 15 ppm
Loss on drying
≤ 0.3 %
Residue on ignition
≤ 0.3 %
Assay (on dry basis)
98.5 to 101.5 %
Residual solvents
passes
Total viable aerobic count
≤ 100 CFU/g
Moulds and yeasts
≤ 10 CFU/g
Salmonella
In 10 g n.d.
Escherichia coli
In 10 g n.d.
Pseudomonas aeruginosa
In 10 g n.d.
Staphylococcus aureus
In 10 g n.d.
General
L-Isoleucine
Stability

Product is stable for 4 years from date of production if stored under recommended conditions in original packaging.

Storage

Dry and dark at room temperature in tightly closed container

Chemical data
Formula
C6H13NO2
CAS Number
73-32-5
Packaging
25 kg Unit
Outer container
Fiber drum
Outer liner
LDPE
Inner liner
LDPE
EP 9 infusion grade
(L-Isoleucine)
Parameter
Limit
Appearance:
White or almost white crystalline powder or flakes
passes
Identity (A. specific optical rotation / B. IR)
passes
Test on turbidity
(5.0 % (m/V) in 1 M HCI)
≤ Ref. Susp. I
Test on colour
(5.0 % (m/V) in 1 M HCI)
≤ BY6
Specific optical rotation (on dry basis)
(4.0 % (m/V) in 25 % HCI at 20 °C [α]D20)
+40.0° to 43.0°
Ninhydrin-positive substances (HPLC)
▪ L-Leucine
▪ L-Valine
▪ Each impurity
▪ Sum of impurities
 
≤ 0.3 %
≤ 0.3 %
≤ 0.2 %
≤ 1.0 %
Ammonium
≤ 0.02 %
Chlorides
≤ 200 ppm
Sulphates
≤ 300 ppm
Iron
≤ 10 ppm
Loss on drying
≤ 0.5 %
Residue on ignition
≤ 0.1 %
Assay (on dry basis)
98.5 to 101.0 %
Total viable aerobic count
≤ 100 CFU/g
Moulds and yeasts
≤ 10 CFU/g
Salmonella
In 1 g n.d.
Escherichia coli
In 1 g n.d.
Pseudomonas aeruginosa
In 1 g n.d.
Staphylococcus aureus
In 1 g n.d.
Endotoxins (LAL-Assay)
< 6 EU/g
General
L-Isoleucine
Stability

Product is stable for 4 years from date of production if stored under recommended conditions in original packaging.

Storage

Dry and dark at room temperature in tightly closed container

Chemical data
Formula
C6H13NO2
CAS Number
73-32-5
Packaging
25 kg Unit
Outer container
Fiber drum
Outer liner
LDPE
Inner liner
LDPE
EP 9 / USP 39 oral grade
(L-Isoleucine)
Parameter
Limit
Appearance:
White or almost white crystalline powder or colourless crystals
passes
Identity (A. specific optical rotation / B. IR)
passes
Test on turbidity
(5.0 % (m/V) in 1 M HCI)
≤ Ref. Susp. I
Test on colour
(5.0 % (m/V) in 1 M HCI)
≤ BY6
pH-value
(1.0 % (m/V) in H2O at 25 °C)
5.5 to 7.0
Specific optical rotation (on dry basis)
(4.0 % (m/V) in 25 % HCI at 20 °C [α]D20)
(4.0 % (m/V) in 6 M HCI at 25 °C [α]D25)
 
+40.0° to +43.0°
+38.9° to +41.8°
Ninhydrin-positive substances (HPLC)
▪ L-Leucine
▪ L-Valine
▪ Each impurity
▪ Sum of impurities
 
≤ 0.3 %
≤ 0.3 %
≤ 0.2 %
≤ 1.0 %
Ammonium
≤ 0.02 %
Chlorides
≤ 200 ppm
Sulphates
≤ 300 ppm
Iron
≤ 10 ppm
Heavy metals
≤ 15 ppm
Loss on drying
≤ 0.3 %
Residue on ignition
≤ 0.1 %
Assay (on dry basis)
98.5 to 101.0 %
Residual solvents
passes
Total viable aerobic count
≤ 100 CFU/g
Moulds and yeasts
≤ 10 CFU/g
Salmonella
In 1 g n.d.
Escherichia coli
In 1 g n.d.
Pseudomonas aeruginosa
In 1 g n.d.
Staphylococcus aureus
In 1 g n.d.
N-Acetyl-L-Tyrosine
General
N-Acetyl-L-Tyrosine
Stability

Product is stable for 4 years from date of production if stored under recommended conditions in original packaging.

Storage

Dry and dark at room temperature in tightly closed container

Chemical data
Formula
C11H13NO4
CAS Number
537-55-3
Packaging
25 kg Unit
Outer container
Fiber drum
Outer liner
LDPE
Inner liner
LDPE
EP 9 oral grade
(N-Acetyl-L-Tyrosine)
Parameter
Limit
Appearance:
White crystalline powder or colourless crystals
passes
Identity
passes
Test on turbidity
(2.5 % (m/V) in H2O)
≤ Ref. Susp. I
Test on colour
(2.5 % (m/V) in H2O)
≤ B9
Specific optical rotation (on dry basis)
(1.0 % (m/V) in H2O at 20 °C [α]D20)
+46.0° to +49.0°
Related substances (HPLC)
▪ Impurity A (Tyrosine)
▪ Unspecific impurities
▪ Total impurities
 
≤ 0.8 %
≤ 0.10 %
≤ 1.00 %
Ammonium
≤ 200 ppm
Chlorides
≤ 200 ppm
Sulphates
≤ 200 ppm
Iron
≤ 20 ppm
Loss on drying
≤ 0.5 %
Residue on ignition
≤ 0.1 %
Assay (on dry basis)
98.5 to 101.0 %
Total viable aerobic count
≤ 1000 CFU/g
Moulds and yeasts
≤ 100 CFU/g
Salmonella
In 1 g n.d.
Escherichia coli
In 1 g n.d.
Pseudomonas aeruginosa
In 1 g n.d.
Staphylococcus aureus
In 1 g n.d.
General
N-Acetyl-L-Tyrosine
Stability

Product is stable for 4 years from date of production if stored under recommended conditions in original packaging.

Storage

Dry and dark at room temperature in tightly closed container

Chemical data
Formula
C11H13NO4
CAS Number
537-55-3
Packaging
25 kg Unit
Outer container
Fiber drum
Outer liner
LDPE
Inner liner
LDPE
EP 9 infusion grade
(N-Acetyl-L-Tyrosine)
Parameter
Limit
Appearance:
White or almost white crystalline powder or colourless crystals
passes
Identity (A. Specific optical rotation / B. IR)
passes
Test on turbidity
(2.5 % (m/V) in H2O)
≤ Ref. Susp. I
Test on colour
(2.5 % (m/V) in H2O)
≤ B9
Specific optical rotation (on dry basis)
(1.0 % (m/V) in H2O at 20 °C [α]D20)
+46.0° to + 49.0°
Related substances (HPLC)
▪ Impurity A (Tyrosine)
▪ Unspecific impurities
▪ Total impurities
 
≤ 0.8 %
≤ 0.10 %
≤ 1.00 %
Ammonium
≤ 200 ppm
Chlorides
≤ 200 ppm
Sulphates
≤ 200 ppm
Iron
≤ 20 ppm
Loss on drying
≤ 0.5 %
Residue on ignition
≤ 0.1 %
Assay (on dry basis)
98.5 to 101.0 %
Total viable aerobic count
≤ 100 CFU/g
Moulds and yeasts
≤ 10 CFU/g
Salmonella
In 1 g n.d.
Escherichia coli
In 1 g n.d.
Pseudomonas aeruginosa
In 1 g n.d.
Staphylococcus aureus
In 1 g n.d.
Endotoxins (LAL-assay)
< 25 IU/g
L-Cystine
General
L-Cystine
Stability

Product is stable for 2 years from date of production if stored under recommended conditions in original packaging.

Storage

Dry and dark at room temperature in tightly closed container

Chemical data
Formula
C6H12N2O4S2
CAS Number
56-89-3
Packaging
25 kg Unit
Outer container
Fiber drum
Outer liner
LDPE
Inner liner
LDPE
EP 8 oral grade
(L-Cystine)
Parameter
Limit
Appearance:
White or almost white crystalline powder
passes
Identity (A and B)
passes
Test on turbidity
(2.5 % (m/V) in H2O)
≤ Ref. Susp. I
Test on colour
(2.5 % (m/V) in H2O)
≤ Y7
Specific optical rotation (on dry basis)
(2.0 % (m/V) in 1 M HCI at 20 °C [α]D20)
–224.0 to –218.0°
Ninhydrin-positive substances (TLC)
≤ 0.2 %
Ninhydrin-positive substances (HPLC)
▪ Any other impurity
▪ Sum of impurities
 
≤ 0.2 %
≤ 0.5 %
Ammonium
≤ 200 ppm
Chlorides
≤ 200 ppm
Sulphates
≤ 300 ppm
Iron
≤ 10 ppm
Heavy metals (as Pb)
≤ 10 ppm
Loss on drying
≤ 0.5 %
Residue on ignition
≤ 0.1 %
Assay (on dry basis)
98.5 to 101.0 %
Total viable aerobic count
< 1000 CFU/g
Moulds and yeasts
< 100 CFU/g
Salmonella
In 1 g n.d.
Escherichia coli
In 1 g n.d.
Pseudomonas aeruginosa
In 1 g n.d.
Staphylococcus aureus
In 1 g n.d.
General
L-Cystine
Stability

Product is stable for 2 years from date of production if stored under recommended conditions in original packaging.

Storage

Dry and dark at room temperature in tightly closed container

Chemical data
Formula
C6H12N2O4S2
CAS Number
56-89-3
Packaging
25 kg Unit
Outer container
Fiber drum
Outer liner
LDPE
Inner liner
LDPE
EP 8 infusion grade
(L-Cystine)
Parameter
Limit
Appearance:
White or almost white crystalline powder
passes
Identity (A and B)
passes
Test on turbidity
(2.5 % (m/V) in H2O)
≤ Ref. Susp. I
Test on colour
(2.5 % (m/V) in H2O)
≤ Y7
Specific optical rotation (on dry basis)
(2.0 % (m/V) in 1 M HCI at 20 °C [α]D20)
–224.0° to –218.0°
Ninhydrin-positive substances (TLC)
≤ 0.2 %
Ninhydrin-positive substances (HPLC)
▪ Any other impurity
▪ Sum of impurities
 
≤ 0.2 %
≤ 0.5 %
Ammonium
≤ 200 ppm
Chlorides
≤ 200 ppm
Sulphates
≤ 300 ppm
Iron
≤ 10 ppm
Heavy metals (as Pb)
≤ 10 ppm
Loss on drying
≤ 0.5 %
Residue on ignition
≤ 0.1 %
Assay (on dry basis)
98.5 to 101.0 %
Total viable aerobic count
< 100 CFU/g
Moulds and yeasts
< 10 CFU/g
Salmonella
In 1 g n.d.
Escherichia coli
In 1 g n.d.
Pseudomonas aeruginosa
In 1 g n.d.
Staphylococcus aureus
In 1 g n.d.
Endotoxins
< 6 EU/g
L-Methionine
General
L-Methionine
Stability

Product is stable for 4 years from date of production if stored under recommended conditions in original packaging.

Storage

Dry and dark at room temperature in tightly closed container

Chemical data
Formula
C5H11NO2S
CAS Number
63-68-3
Packaging
25 kg Unit
Outer container
Fiber drum
Outer liner
PE
Inner liner
PE
USP 39 oral grade
(L-Methionine)
Parameter
Limit
Appearance:
White or almost white crystalline powder or colourless crystals
passes
Identity (A. IR)
passes
Specific optical rotation (on dry basis)
(2.0 % (m/V) in 6 N HCI at 25 °C [α]D25)
+22.4° to +24.7°
Ninhydrin-positive substances (TLC)
▪ Each
▪ total
 
≤ 0.5 %
≤ 2.0 %
Chlorides
≤ 500 ppm
Sulphates
≤ 300 ppm
Iron
≤ 30 ppm
Heavy metals (as Pb)
≤ 15 ppm
pH (1.0 % (m/V) in H2O)
5.6 to 6.1
Loss on drying
≤ 0.3 %
Sulphates ash
≤ 0.4 %
Assay (on dry basis)
98.5 to 101.05 %
Total viable aerobic count
< 1000 CFU/g
Moulds and yeasts
< 100 CFU/g
Salmonella
In 10 g n.d.
Escherichia coli
In 10 g n.d.
Pseudomonas aeruginosa
In 10 g n.d.
Staphylococcus aureus
In 10 g n.d.
General
L-Methionine
Stability

Product is stable for 4 years from date of production if stored under recommended conditions in original packaging.

Storage

Dry and dark at room temperature in tightly closed container

Chemical data
Formula
C5H11NO2S
CAS Number
63-68-3
Packaging
25 kg Unit
Outer container
Fiber drum
Outer liner
LDPE
Inner liner
LDPE
EP 9 infusion grade
(L-Methionine)
Parameter
Limit
Appearance:
White or almost white crystalline powder or colourless crystals
passes
Identity (A. Specific optical rotation / B. IR)
passes
Specific optical rotation (on dry basis)
(2.0 % in 25 % HCI at 20 °C [α]D20)
+22.5° to +24.0°
Test on turbidity
(2.5 % (m/V) in H2O)
≤ Ref. Susp. I
Test on colour
(2.5 % (m/V) in H2O)
≤ B9
Related substances (HPLC)
▪ Unspecific impurities
▪ Total
▪ Phenylalanine
 
≤ 0.10 %
≤ 0.3 %
≤ 0.20 %
O-Acetyl-L-homoserine (AAA)
≤ 0.20 %
Chlorides
≤ 200 ppm
Ammonium
≤ 200 ppm
Sulphates
≤ 300 ppm
Iron
≤ 10 ppm
pH (2.5 % (m/V) in H2O)
5.5 to 6.5
Loss on drying
≤ 0.5 %
Sulphated ash
≤ 0.1 %
Assay (on dry basis)
99.0 to 101.0 %
Total viable aerobic count
≤ 100 CFU/g
Moulds and yeasts
≤ 10 CFU/g
Salmonella
In 1 g n.d.
Escherichia coli
In 1 g n.d.
Pseudomonas aeruginosa
In 1 g n.d.
Staphylococcus aureus
In 1 g n.d.
Endotoxins
< 6 EU/g
General
L-Methionine
Stability

Product is stable for 4 years from date of production if stored under recommended conditions in original packaging.

Storage

Dry and dark at room temperature in tightly closed container

Chemical data
Formula
C5H11NO2S
CAS Number
63-68-3
Packaging
25 kg Unit
Outer container
Fiber drum
Outer liner
LDPE
Inner liner
LDPE
EP 9 oral grade
(L-Methionine)
Parameter
Limit
Appearance:
White or almost white crystalline powder or colourless crystals
passes
Identity (A. Specific optical rotation / B. IR)
passes
Specific optical rotation (on dry basis)
(2.0 % in 25 % HCI at 20 °C [α]D20)
+22.5° to +24.0°
Test on turbidity
(2.5% (m/V) in H2O)
≤ Ref. Susp. I
Test on colour
(2.5 % (m/V) in H2O)
≤ B9
Related substances (HPLC)
▪ Unspecific impurities
▪ Total
▪ Phenylalanine
 
≤ 0.10 %
≤ 0.3 %
≤ 0.20 %
O-Acetyl-L-homoserine (AAA)
≤ 0.20 %
Chlorides
≤ 200 ppm
Ammonium
≤ 200 ppm
Sulphates
≤ 300 ppm
Iron
≤ 10 ppm
pH (2.5 % (m/V) in H2O)
5.5 to 6.5
Loss on drying
≤ 0.5 %
Sulphated ash
≤ 0.1 %
Assay (on dry basis)
99.0 to 101.0 %
Total viable aerobic count
≤ 1000 CFU/g
Moulds and yeasts
≤ 100 CFU/g
Salmonella
In 1 g n.d.
Escherichia coli
In 1 g n.d.
Pseudomonas aeruginosa
In 1 g n.d.
Staphylococcus aureus
In 1 g n.d.
General
L-Methionine
Stability

Product is stable for 4 years from date of production if stored under recommended conditions in original packaging.

Storage

Dry and dark at room temperature in tightly closed container

Chemical data
Formula
C5H11NO2S
CAS Number
63-68-3
Packaging
25 kg Unit
Outer container
Fiber drum
Outer liner
LDPE
Inner liner
LDPE
EP 9 / USP 39 oral grade
(L-Methionine)
Parameter
Limit
Appearance:
White or almost white crystalline powder or colourless crystals
passes
Identity (A. Specific optical rotation / B. IR)
passes
Specific optical rotation (on dry basis)
(2.0 % in 25 % HCI at 20 °C [α]D20
+22.5° to +24.0°
Test on turbidity
(2.5 % (m/V) in H2O)
≤ Ref. Susp. I
Test on colour
(2.5 % (m/V) in H2O)
≤ B9
Ninhydrin-positive substances (TLC)
▪ Each
▪ total
 
≤ 0.5 %
≤ 2.0 %
Related substances (HPLC)
▪ Unspecific impurities
▪ Total
▪ Phenylalanine
 
≤ 0.10 %
≤ 0.3 %
≤ 0.20 %
O-Acetyl-L-homoserine (AAA)
≤ 0.20 %
Chlorides
≤ 200 ppm
Ammonium
≤ 200 ppm
Sulphates
≤ 300 ppm
Iron
≤ 10 ppm
Heavy metals (as Pb)
≤ 10 ppm
pH-value
(2.5 % (m/V) in H2O)
(1.0 % (m/V) in H2O)
 
5.5 to 6.5
5.6 to 6.1
Loss on drying
≤ 0.3 %
Sulphated ash
≤ 0.1 %
Assay (on dry basis)
99.0 to 101.0 %
Total viable aerobic count
< 1000 CFU/g
Moulds and yeasts
< 100 CFU/g
Salmonella
In 10 g n.d.
Escherichia coli
In 10 g n.d.
Pseudomonas aeruginosa
In 10 g n.d.
Staphylococcus aureus
In 10 g n.d.
L-Leucine
General
L-Leucine
Stability

Product is stable for 4 years from date of production if stored under recommended conditions in original packaging.

Storage

Dry and dark at room temperature in tightly closed container

Chemical data
Formula
C6H13NO2
CAS Number
61-90-5
Packaging
25 kg Unit
Outer container
Fiber drum
Outer liner
LDPE
Inner liner
LDPE
EP 9 / USP 39 oral grade
(L-Leucine)
Parameter
Limit
Appearance:
White or almost white crystalline poweder or shiny flakes
passes
Identity (A. Specific optical rotation / B. IR)
passes
Test on turbidity
(5.0 % (m/V) in 1 M HCI)
≤ Ref. Susp. I
Test on colour
(5.0 % (m/V) in 1 M HCI)
≤ BY6
pH-value
(1.0 % (m/V) in H2O at 25 °C)
5.5 to 7.0
Specific optical rotation (on dry basis)
(4.0 % (m/V) in 25 % HCI at 20 °C [α]D20)
(4.0 % (m/V) in 6 M HCI at 25 °C [α]D25)
 
+14.5° to +16.5°
+14.9° to +17.3°
Ninhydrin-positive substances (TLC)
passes
Related substances (AAA)
▪ L-Isoleucine
▪ Each impurity
▪ Sum of impurities
 
≤ 0.8 %
≤ 0.2 %
≤ 1.0 %
Ammonium
≤ 0.02 %
Chlorides
≤ 200 ppm
Sulphates
≤ 300 ppm
Iron
≤ 10 ppm
Heavy metals (as Pb)
≤ 15 ppm
Loss on drying
≤ 0.2 %
Residue on ignition
≤ 0.1 %
Assay (on dry basis)
98.5 to 101.0 %
Residual solvents
passes
Total viable aerobic count
< 100 CFU/g
Moulds and yeasts
< 10 CFU/g
Salmonella
In 10 g n.d.
Escherichia coli
In 10 g n.d.
Pseudomonas aeruginosa
In 10 g n.d.
Staphylococcus aureus
In 10 g n.d.
General
L-Leucine
Stability

Product is stable for 4 years from date of production if stored under recommended conditions in original packaging.

Storage

Dry and dark at room temperature in tightly closed container

Chemical data
Formula
C6H13NO2
CAS Number
61-90-5
Packaging
25 kg Unit
Outer container
Fiber drum
Outer liner
LDPE
Inner
LDPE
EP 9 infusion grade
(L-Leucine)
Parameter
Limit
Appearance:
White or almost white crystalline powder or shiny flakes
passes
Identity (A. Specific optical rotation / B. IR)
passes
Test on turbidity
(5.0 % (m/V) in 1 M HCI)
≤ Ref. Susp. I
Test on colour
(5.0 % (m/V) in 1 M HCI)
≤ BY6
Specific optical rotation (on dry basis)
(4.0 % (m/V) in 25 % HCI at 20 °C [α]D20)
+14.5° to +16.5°
Related substances (AAA)
▪ L-Isoleucine
▪ Each impurity
▪ Sum of impurities
 
≤ 0.8 %
≤ 0.2 %
≤ 1.0 %
Ammonium
≤ 0.02 %
Chlorides
≤ 200 ppm
Sulphates
≤ 300 ppm
Iron
≤ 10 ppm
Loss on drying
≤ 0.5 %
Sulphated ash
≤ 0.1 %
Assay (on dry basis)
98.5 to 101.0 %
Total viable aerobic count
< 100 CFU/g
Moulds and yeasts
< 10 CFU/g
Salmonella
In 1 g n.d.
Escherichia coli
In 1 g n.d.
Pseudomonas aeruginosa
In 1 g n.d.
Staphylococcus aureus
In 1 g n.d.
Endotoxins (LAL-Assay)
< 6 EU/g
General
L-Leucine
Stability

Product is stable for 4 years from date of production if stored under recommended conditions in original packaging.

Storage

Dry and dark at room temperature in tightly closed container

Chemical data
Formula
C6H13NO2
CAS Number
61-90-5
Packaging
25 kg Unit
Outer container
Fiber drum
Outer liner
LDPE
Inner liner
LDPE
EP 9 oral grade
(L-Leucine)
Parameter
Limit
Appearance:
White or almost white crystalline powder or shiny flakes
passes
Identity (A. Specific optical rotation / B. IR)
passes
Test on turbidity
(5.0 % (m/V) in 1 M HCI)
≤ Ref. Susp. I
Test on colour
(5.0 % (m/V) in 1 M HCI)
≤ BY6
Specific optical rotation (on dry basis)
(4.0 % (m/V) in 25 % HCI at 20 °C [α]D20)
+14.5° to +16.5°
Related substances (AAA)
▪ L-Isoleucine
▪ Each impurity
▪ Sum of impurities
 
≤ 0.8 %
≤ 0.2 %
≤ 1.0 %
Ammonium
≤ 0.02 %
Chlorides
≤ 200 ppm
Sulphates
≤ 300 ppm
Iron
≤ 10 ppm
Loss on drying
≤ 0.5 %
Sulphated ash
≤ 0.1 %
Assay (on dry basis)
98.5 to 101.0 %
Total viable aerobic count
< 1000 CFU/g
Moulds and yeasts
< 100 CFU/g
Salmonella
In 1 g n.d.
Escherichia coli
In 1 g n.d.
Pseudomonas aeruginosa
In 1 g n.d.
Staphylococcus aureus
In 1 g n.d.
General
L-Leucine
Stability

Product is stable for 4 years from date of production if stored under recommended conditions in original packaging.

Storage

Dry and dark at room temperature in tightly closed container

Chemical data
Formula
C6H13NO2
CAS Number
61-90-5
Packaging
25 kg Unit
Outer container
Fiber drum
Outer liner
LDPE
Inner liner
LDPE
USP 39 oral grade
(L-Leucine)
Parameter
Limit
Appearance:
White crystalline powder
passes
Identity
passes
pH
(1.0 % (m/V) in H2O at 25 °C)
5.5 to 7.0
Specific optical rotation (on dry basis)
(4.0 % (m/V) in 6 M HCI at 25 °C [α]D25)
+14.9° to +17.3°
Ninhydrin-positive substances
passes
Chlorides
≤ 500 ppm
Sulphates
≤ 300 ppm
Iron
≤ 30 ppm
Loss on drying
≤ 0.2 %
Residue on ignition
≤ 0.4 %
Assay (on dry basis)
98.5 to 101.5%
Residual solvents
passes
Total viable aerobic count
≤ 100 CFU/g
Moulds and yeasts
≤ 10 CFU/g
Salmonella
In 10 g n.d.
Escherichia coli
In 10 g n.d.
Pseudomonas aeruginosa
In 10 g n.d.
Staphylococcus aureus
In 10 g n.d.
L-Histidine
General
L-Histidine
Stability

Product is stable for 2 years from date of production if stored under recommended conditions in original packaging.

Storage

Dry and dark at room temperature in tightly closed container

Chemical data
Formula
C6H9N3O2
CAS Number
71-00-1
Packaging
25 kg Unit
Outer container
Fiber drum
Outer liner
LDPE
Inner liner
LDPE
EP 9 infusion grade
(L-Histidine)
Parameter
Limit
Appearance:
White or almost white crystalline powder or colourless crystals
passes
Identity (A. Specific optical rotation / B. IR)
passes
Test on turbidity
(5.0 % (m/V) in H2O)
≤ Ref. Susp. I
Test on colour
(5.0 % (m/V) in H2O)
≤ BY7
Specific optical rotation (on dry basis)
(dissolve 2.75 g in 12.0 mL 25 % [m/V] HCI and dilute to 25.0 mL H2O, at 20 °C [α]D20)
+11.4° to +12.4°
Ninhydrin-positive substances (AAA)
▪ Any other impurity
▪ Total impurities
 
≤ 0.2 %
≤ 0.5 %
Ammonium
≤ 0.02 %
Chlorides
≤ 200 ppm
Sulphates
≤ 300 ppm
Iron
≤ 10 ppm
Loss on drying
≤ 0.5 %
Residue on ignition
≤ 0.1 %
Assay (on dry basis)
98.5 to 101.0 %
Total viable aerobic count
< 100 CFU/g
Moulds and yeasts
< 10 CFU/g
Salmonella
In 10 g n.d.
Escherichia coli
In 10 g n.d.
Pseudomonas aeruginosa
In 10 g n.d.
Staphylococcus aureus
In 10 g n.d.
Endotoxins (LAL-assay)
< 6 EU/g
General
L-Histidine
Stability

Product is stable for 2 years from date of production if stored under recommended conditions in original packaging.

Storage

Dry and dark at room temperature in tightly closed container

Chemical data
Formula
C6H9N3O2
CAS Number
71-00-1
Packaging
25 kg Unit
Outer container
Fiber drum
Outer liner
LDPE
Inner liner
LDPE
EP 9 oral grade
(L-Histidine)
Parameter
Limit
Appearance:
White or almost white crystalline powder or colourless crystals
passes
Identity (A. Specific optical rotation / B. IR)
passes
Test on turbidity
(5.0 % (m/V) in H2O)
≤ Ref. Susp. I
Test on colour
(5.0 % (m/V) in H2O)
≤ BY7
Specific optical rotation (on dry basis)
(dissolve 2.75 g in 12.0 mL 25 % [m/V] HCI and dilute to 25.0 mL with H2O, at 20 °C [α]D20)
+11.4° to +12.4°
Ninhydrin-positive substances (AAA)
▪ Any other impurity
▪ Total impurities
 
≤ 0.2 %
≤ 0.5 %
Ammonium
≤ 0.02 %
Chlorides
≤ 200 ppm
Sulphates
≤ 300 ppm
Iron
≤ 10 ppm
Loss on drying
≤ 0.5 %
Residue on ignition
≤ 0.1 %
Assay (on dry basis)
98.5 to 101.0 %
Total viable aerobic count
< 1000 CFU/g
Moulds and yeasts
< 100 CFU/g
Salmonella
In 10 g n.d.
Escherichia coli
In 10 g n.d.
Pseudomonas aeruginosa
In 10 g n.d.
Staphylococcus aureus
In 10 g n.d.
L-Phenylalanine
General
L-Phenylalanine
Stability

Product is stable for 4 years from date of production if stored under recommended conditions in original packaging.

Storage

Dry and dark at room temperature in tightly closed container

Chemical data
Formula
C9H11NO2
CAS Number
63-91-2
Packaging
25 kg Unit
Outer container
Fiber drum
Outer liner
LDPE
Inner liner
LDPE
EP 9 infusion grade
(L-Phenylalanine)
Parameter
Limit
Appearance:
White or almost white crystalline powder or shiny white flakes
passes
Identity (A. specific optical rotation / B. IR)
passes
Test on turbidity
(5.0 % (m/V) in 1 M HCI)
≤ Ref. Susp. I
Test on colour
(5.0 % (m/V) in 1 M HCI)
≤ BY6
Specific optical rotation (on dry basis)
(2.0 % (m/V) in H2O at 20 °C [α]D20)
–35.5° to –33.0°
Ninhydrin-positive substances (HPLC)
▪ Each impurity
▪ Total impurities
 
≤ 0.2 %
≤ 0.5 %
Ammonium
≤ 0.02 %
Chlorides
≤ 200 ppm
Sulphates
≤ 300 ppm
Iron
≤ 10 ppm
Loss on drying
≤ 0.5 %
Residue on ignition
≤ 0.1 %
Assay (on dry basis)
98.5 to 101.0 %
Total viable aerobic count
≤ 100 CFU/g
Moulds and yeasts
≤ 10 CFU/g
Salmonella
In 1 g n.d.
Escherichia coli
In 1 g n.d.
Pseudomonas aeruginosa
In 1 g n.d.
Staphylococcus aureus
In 1 g n.d.
Endotoxins (KTM-Assay)
< 6 EU/g
General
L-Phenylalanine
Stability

Product is stable for 4 years from date of production if stored under recommended conditions in original packing.

Storage

Dry and dark at room temperature in tightly closed container

Chemical data
Formula
C9H11NO2
CAS Number
63-91-2
Packaging
25 kg Unit
Outer container
Fiber drum
Outer liner
LDPE
Inner liner
LDPE
EP 9 oral grade
(L-Phenylalanine)
Parameter
Limit
Appearance:
White or almost white crystalline powder or shiny white flakes
passes
Identity (A. specific optical rotation / B. IR)
passes
Test on turbidity
(5.0 % (m/V) in 1 M HCI)
≤ Ref. Susp. I
Test on colour
(5.0 % (m/V) in 1 M HCI)
≤ BY6
Specific optical rotation (on dry basis)
(2.0 % (m/V) in H2O at 20 °C [α]D20)
–35.5° to –33.0°
Ninhydrin-positive substances (HPLC)
▪ Each impurity
▪ Total impurities
 
≤ 0.2 %
≤ 0.5 %
Ammonium
≤ 0.02 %
Chlorides
≤ 200 ppm
Sulphates
≤ 300 ppm
Iron
≤ 10 ppm
Loss on drying
≤ 0.5 %
Residue on ignition
≤ 0.1 %
Assay (on dry basis)
98.5 to 101.0 %
Total viable aerobic count
≤ 1000 CFU/g
Moulds and yeasts
≤ 100 CFU/g
Salmonella
In 1 g n.d.
Escherichia coli
In 1 g n.d.
Pseudomonas aeruginosa
In 1 g n.d.
Staphylococcus aureus
In 1 g n.d.
General
L-Phenylalanine
Stability

Product is stable for 4 years from date of production if stored under recommended conditions in original packaging.

Storage

Dry and dark at room temperature in tightly closed container

Chemical data
Formula
C9H11NO2
CAS Number
63-91-2
Packaging
25 kg Unit
Outer container
Fiber drum
Outer liner
LDPE
Inner liner
LDPE
EP 9 / USP 39 oral grade
(L-Phenylalanine)
Parameter
Limit
Appearance:
White or almost white crystalline powder or shiny white flakes
passes
Identity
passes
Test on turbidity
(5.0 % (m/V) in 1 M HCI)
≤ Ref. Susp. I
Test on colour
(5.0 % (m/V) in 1 M HCI)
≤ BY6
pH-value
(1.0 % (m/V) in H2O at 25 °C)
5.4 to 6.0
Specific optical rotation (on dry basis)
(2.0 % (m/V) in H2O at 20 °C [α]D20)
(2.0 % (m/V) in H2O at 20 °C [α]D20)
 
–35.5° to –33.0°
–34.7° to –32.7°
Ninhydrin-positive substances (TLC)
passes
Ninhydrin-positive substances (HPLC)
▪ Each impurity
▪ Total impurities
 
≤ 0.2 %
≤ 0.5 %
Ammonium
≤ 0.02 %
Chlorides
≤ 200 ppm
Sulphates
≤ 300 ppm
Iron
≤ 10 ppm
Heavy metals (as Pb)
≤ 15 ppm
Loss on drying
≤ 0.3 %
Residue on ignition
≤ 0.1 %
Assay (on dry basis)
98.5 to 101.0 %
Residual solvents
passes
Total viable aerobic count
≤ 100 CFU/g
Moulds and yeasts
≤ 10 CFU/g
Salmonella
In 10 g n.d.
Escherichia coli
In 10 g n.d.
Pseudomonas aeruginosa
In 10 g n.d.
Staphylococcus aureus
In 10 g n.d.
General
L-Phenylalanine
Stability

Product is stable for 4 years from date of production if stored under recommended conditions in original packaging.

Storage

Dry and dark at room temperature in tightly closed container

Chemical data
Formula
C9H11NO2
CAS Number
63-91-2
Packaging
25 kg Unit
Outer container
Fiber drum
Outer liner
LDPE
Inner liner
LDPE
USP 39 oral grade
(L-Phenylalanine)
Parameter
Limit
Appearance:
White or almost white crystalline powder or shiny, white flakes
passes
Identity
passes
pH-value
(1.0 % (m/V) in 1 H2O at 25 °C)
5.4 to 6.0
Specific optical rotation (on dry basis)
(2.0 % (m/V) in H2O at 25 °C [α]D25)
–34.7° to –32.7°
Ninhydrin-positive substances (TLC)
passes
Chlorides
≤ 500 ppm
Sulphates
≤ 300 ppm
Iron
≤ 30 ppm
Heavy metals (as Pb)
≤ 15 ppm
Loss on drying
≤ 0.3 %
Residue on ignition
≤ 0.4 %
Assay (on dry basis)
98.5 to 101.5 %
Residual solvents
passes
Total viable aerobic count
< 100 CFU/g
Moulds and yeasts
< 10 CFU/g
Salmonella
In 10 g n.d.
Escherichia coli
In 10 g n.d.
Pseudomonas aeruginosa
In 10 g n.d.
Staphylococcus aureus
In 10 g n.d.
L-Tyrosine
General
L-Tyrosine
Stability

Product is stable for 4 years from date of production if stored under recommended conditions in original packaging.

Storage

Dry and dark at room temperature in tightly closed container

Chemical data
Formula
C9H11NO3
CAS Number
60-18-4
Packaging
25 kg Unit
Outer container
Fiber drum
Outer liner
LDPE
Inner liner
LDPE
EP 9 infusion grade
(L-Tyrosine)
Parameter
Limit
Appearance:
White or almost white crystalline powder or colourless crystals
passes
Identity (A. Specific optical rotation / B. IR)
passes
Test on turbidity
{2.5 % (m/V) in 7 % HCI)
≤ Ref. Susp. I
Test on colour
(2.5 % (m/V) in 7 % HCI)
≤ Y7
Specific optical rotation (on dry basis)
(5.0 % (m/V) in 3.5 % HCI at 20 °C [α]D20)
–12.3° to –11.0°
Ninhydrin-positive substances (HPLC)
▪ L-Phenylalanine
▪ Each impurity
▪ Total impurities
 
≤ 0.5 %
≤ 0.2 %
≤ 0.6 %
Ammonium
≤ 0.02 %
Chlorides
≤ 200 ppm
Sulphates
≤ 300 ppm
Iron
≤ 10 ppm
Loss on drying
≤ 0.5 %
Residue on ignition
≤ 0.1 %
Assay (on dry basis)
99.0 to 101.0 %
Total viable aerobic count
≤ 100 CFU/g
Moulds and yeasts
≤ 10 CFU/g
Salmonella
In 1 g n.d.
Escherichia coli
In 1 g n.d.
Pseudomonas aeruginosa
In 1 g n.d.
Staphylococcus aureus
In 1 g n.d.
Endotoxins (KTM-assay)
< 6 EU/g
General
L-Tyrosine
Stability

Product is stable for 4 years from date of production if stored under recommended conditions in original packaging.

Storage

Dry and dark at room temperature in tightly closed container

Chemical da